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Mandatory Federal Workplace Drug Testing Guidelines

Below is the complete
(and rather complex) text of the Mandatory Guidelines for Federal
Workplace Drug Testing Programs, published by the Substance Abuse and
Mental Health Services Administration (SAMHSA).

Note that other government entities might modify the SAMHSA guidelines
to their own specifications. For example, the U.S. Department of
Transportation (DOT) has its own set
of procedures, which are often referenced as the model. Most labs and
government and private-sector employers go by either the SAMHSA or DOT
procedures. If you work in an industry (in either the government or
private sector) that correlates with one regulated by a government agency,
you might want to check the agency's Web site
to see which model it uses, or for its own procedures.

This is the
"master" document published on June 9, 1994 and
effective September 1. It serves as the base for all future
revisions, and several have been published since 1994 (e.g.,
amendments to drug cutoff levels). Revising it is on-going
process, however, the entire document is typically not
republished. Instead, the revisions alone are published and stored
in the Federal Register as notices and other documents. It is
impractical to display all of them here, but you may search for
revisions in the Federal
Register or at the SAMHSA
Workplace Resource Center.

Substance Abuse and Mental Health Services
Administration

Mandatory Guidelines for Federal Workplace Drug Testing
Programs

SUMMARY: The Department of Health and Human Services (HHS)
revises some of the scientific and technical guidelines for Federal drug
testing programs and revises certain standards for certification of
laboratories engaged in urine drug testing for Federal agencies.

SUPPLEMENTAL INFORMATION: The
Department is revising the guidelines entitled "Mandatory Guidelines
for Federal Workplace Drug Testing Programs," (Mandatory Guidelines)
which were initially published in the Federal Register on April 11, 1988
(53 FR 11979). These Mandatory Guidelines and the revisions are developed
in accordance with Executive Order No. 12564 dated September 15, 1986, and
section 503 of Pub. L. 100-71, 5 U.S.C. section 7301 note, the
Supplemental Appropriations Act for fiscal year 1987 dated July 11, 1987.
The revisions to the Mandatory Guidelines incorporate changes based on the
comments submitted and the Department's first 5 years of experience in
implementing and administering these Guidelines.

BACKGROUND AND SUMMARY OF PUBLIC COMMENTS AND POLICIES OF THE
REVISED GUIDELINES:

A. Proposed Revised Mandatory Guidelines

The basic purpose of the Mandatory Guidelines is to establish
scientific and technical guidelines for Federal agencies' Workplace drug
testing programs and to establish a certification program for laboratories
engaged in urine drug testing for Federal agencies. The proposed revisions
published in the Federal Register on January 25, 1993 (58 FR 6062),
retained the basic requirements in the Mandatory Guidelines published in
the Federal Register on April 11, 1988, but as indicated above
refined some requirements in order to incorporate changes based on the
Department's first 5 years of experience in implementing and administering
these Guidelines.

The major changes proposed in the notice published in the Federal
Register on January 25, 1993, are summarized here to facilitate the
discussion of the comments received during the public comment period.

The Department proposed reducing the requirement to collect 60 mL of
urine at the collection site to 30 mL. This change was proposed because
many times donors have difficulty in providing the 60 mL of urine. In
addition, 30 mL is adequate to complete the required testing and satisfy
other program requirements.

The Department proposed to revise the specimen collection procedure to
allow Federal agencies to use an optional "split specimen"
collection procedure. Several Federal agencies have been granted waivers
to use split specimen collection procedures during the past 5 years.
Establishing a "split specimen" procedure will ensure that each
Federal agency will be using the same procedure. The Department believes
that appropriate guidance must be provided regarding the minimum
acceptable volumes for the split specimens, measuring temperature before a
single donor specimen is transferred into two separate specimen bottles,
sending both split specimen bottles to the laboratory at the same time to
ensure that they are subject to the same shipping and storage conditions,
and specifying the procedures for testing Bottle B when the Bottle A
specimen is reported positive.

The Department proposed to revise the collection procedure to allow
Federal agencies to use an individual of the same gender, other than a
collection site employee, to observe the collection of a specimen whenever
there is reason to believe the individual may have altered or substituted
the specimen. This change is based on the understanding that it is not
always possible to have a collection site employee of the same gender
observe the collection.

The Department proposed a change to allow a laboratory to use a
certifying scientist who is only certified to review initial drug tests
which are negative. This could assist in reducing the cost of testing
without compromising the reliability of drug testing.

The Department proposed that the initial test level for marijuana
metabolites be reduced from 100 ng/mL to 50 ng/mL. This change reflects
advances in technology of immunoassay tests for marijuana metabolites.

The Department proposed to allow laboratories to use multiple
immunoassay tests for the same drug or drug class. This would allow
laboratories to use an initial test and then forward all presumptive
positives for a second test by a different immunoassay technique to
minimize possible presumptive positives due to the presence of structural
analogues in the specimen. In addition, this policy would allow a
laboratory to use a different immunoassay for specimens that may be
untestable with one immunoassay.

The Department proposed that in order to report a specimen positive for
only methamphetamine, the specimen must also contain the metabolite
amphetamine at a concentration equal to or greater than 200 ng/mL by the
confirmatory test. This proposed requirement would ensure that high
concentrations of sympathomimetic amines available in over-the-counter and
prescription medications will not be misidentified as methamphetamine.

The Department proposed reducing the number of blind samples a Federal
agency must submit each quarter to its contracting laboratory from 10% of
all samples to a minimum of 3% (with a maximum of 100 blind samples). This
proposed change may significantly reduce the costs associated with
maintaining a blind sample program without affecting the Federal agency's
ability to monitor a laboratory's performance.

The performance testing sample portion of the laboratory certification
program was proposed to be changed by reducing the performance testing
(PT) challenges for certified laboratories from 6 cycles per year to 4
cycles per year. Experience in this and other performance testing programs
indicates that 4 cycles per year is sufficient to assess a laboratory's
ability to test and report results for performance testing samples.

The Department proposed restricting the types of arrangements that can
exist between the Medical Review Officer (MRO) and the laboratory to
ensure that a conflict of interest does not exist. The restrictions would
require that the agency's MRO not be an employee or an agent of, or have
any financial interest in, the laboratory for which the MRO is reviewing
drug testing results. Similarly, the laboratory would be prohibited from
entering into any agreement with an MRO that could be construed as a
conflict of interest.

A new subpart D was proposed which provides detailed procedures for the
internal review of a suspension or proposed revocation of a laboratory's
certification to perform drug testing. These procedures will ensure and
provide a timely and fair review of all suspensions or proposed
revocations.

The Department proposed that the written notice of the suspension which
is sent to the laboratory, as well as the reviewing official's written
decision upholding or denying suspension or proposed revocation under the
review procedures in subpart D, would be made available to the public upon
request. This provision ensures that the public has access to the
documents containing the basis for HHS's actions.

B. Public Comments and the Department's Responses

The Department received 73 public comments on the proposed changes from
Federal agencies, individuals, organizations, and companies. About 50% of
these supported all or some of the proposed changes. All written comments
were reviewed and taken into consideration in the preparation of the
revised Mandatory Guidelines. The substantive concerns raised in the
public comments and the Department's responses to the comments are set out
below. Similar comments are considered together.

1. Definitions

A number of commenters expressed concerns with the definitions in
section 1.2. It was suggested that the definition for chain of custody
indicate that couriers do not need to document chain of custody while the
specimens are in transit to the laboratory. The Department agrees that the
Mandatory Guidelines should be clarified to address that issue.

Specimens are sealed in packages and any tampering with a sealed
specimen would be noticed by the laboratory and documented on the specimen
chain of custody. In addition, as a practical matter, couriers, express
couriers, and postal service personnel do not have access to the specimen
chain of custody form since the form is inside the sealed package. Section
2.2(i) of the Mandatory Guidelines that discusses the transportation of a
specimen to a laboratory has been revised to clarify this point.

One commenter recommended that the definitions in the Guidelines
conform to the definitions established by the National Committee for
Clinical Laboratory Standards (NCCLS) since the proposed definitions may
be in conflict with the efforts of that nonprofit, educational
organization. The Department fully supports the efforts of this committee
to develop standard definitions since a common understanding of
definitions is essential for maintaining a high level of performance
within laboratory testing programs. The Department has revised the
definitions in section 1.2 to ensure that they are consistent with those
proposed currently by NCCLS. The Department has changed the proposed
definitions for calibrator, control, and standard as well as included new
definitions for donor, specimen, sample, and quality control sample. The
Department also made appropriate changes in other sections of the
Guidelines to ensure that the terms used were consistent with these new
definitions. The Department notes, however, that these changes are not
substantive, but rather are technical in nature to clarify the
definitions. The Department believes these changes will eliminate the
confusion expressed by several other commenters regarding the use of these
terms in other sections of the Guidelines.

One commenter believes the proposed definition for the certifying
scientist should specifically state that the individual understands chain
of custody. The Department intended that the definition of certifying
scientist include that the individual have a thorough understanding of
chain of custody, since it was proposed that such individual have
"training and experience in the theory and practice of all methods
and procedures used in the laboratory." See section 1.2. However, in
order to prevent any confusion, the definition has been changed to clarify
this issue. One commenter suggested that the Secretary require a
certifying scientist to possess at least a masters degree, so they would
be equal to experts presented by an employee who is contesting the result
in court or in an administrative proceeding. Based on the Department's
experience, there are numerous highly qualified individuals serving as
certifying scientists who possess bachelors' degrees, and who have the
expertise to testify as to the records they have certified. These
certifying scientists do not need to be qualified as experts in
litigation, as the defense may qualify someone else in the laboratory or
outside the laboratory to perform this function, if necessary. Further,
the Department believes that requiring higher educational requirements
would place an unnecessary burden on the laboratories, as well as
eliminate many qualified individuals from serving as certifying
scientists.

One commenter believes the requirement to use an Office of Management
and Budget (OMB) approved specimen chain of custody form requires the
laboratories to use OMB approved laboratory chain of custody forms. This
interpretation is incorrect. The Department proposed that such forms be
used only for specimen chain of custody forms, not laboratory chain of
custody forms. The Department believes that standard specimen chain of
custody forms are important to ensure that collection sites have a
consistent form so as to reduce any errors or incomplete documentation
when filling out the forms.

One commenter noted that the Department's proposed definition of an
immunoassay test is ambiguous and does not support the policy that allows
using a second immunoassay test for specimens that are presumptively
positive for amphetamines. Specifically, the term "initial test"
was proposed to be defined as "[a]n immunoassay test to eliminate
"negative" urine specimens from further consideration and to
identify the class of drugs that requires confirmation." The
Department agrees with the commenter that the definition is ambiguous. The
Department supports allowing laboratories to perform multiple immunoassay
tests for the same drug or drug class. Therefore, the Department has
clarified the definition to ensure that further testing is consistent with
section 2.4(e)(4) which permits conducting multiple initial tests.

2. Dilution/Adulteration Tests

Several commenters concurred with section 2.1(c) which clarifies that
laboratories may conduct dilution/adulteration testing to determine the
validity of the specimen while some commenters sought to have the
Secretary define the specific tests to be conducted and require that such
tests be performed. The issue regarding the types of dilution/adulteration
testing to be performed has been highly controversial among forensic
laboratory professionals since there is a lack of data to suggest that
dilution/adulteration testing can clearly identify a donor who has
intentionally taken a substance to affect the outcome of a drug test or
has otherwise diluted or adulterated the specimen. At this time, the
Department believes that such testing should remain optional and the
selection of tests to be conducted for possible dilution/adulteration and
the cutoff levels for such tests, if conducted, should be determined by
the laboratories based on their best judgment.

Two commenters requested that the Department allow
dilution/adulteration testing to be conducted at the collection site. The
Department believes that it is better able to monitor the performance of
such testing when it is conducted by laboratory personnel, rather than
require agencies to monitor such testing at the collection sites. During
the laboratory inspection process, the Department is able to evaluate the
laboratories' performance of such testing to ensure that tests are
performed properly, chain of custody is not broken, and
cross-contamination does not occur from one donor specimen to another
which could impact the integrity of a specimen. The MRO can review the
results of the dilution/adulteration tests and make a decision on the
basis of the test and on his or her interview of the donor to determine
whether a medical factor may have contributed to the results of such
testing. In addition, disallowing the use of dilution/adulteration testing
at the collection site ensures that agency employees are not unnecessarily
subject to observed collection and thus protects the privacy of
individuals to the maximum extent possible.

3. Specimen Collection Procedure

With regard to the specimen collection procedure, a number of
commenters were highly supportive of reducing the required volume of a
urine specimen from 60 mL to 30 mL as stated in section 2.2(f)(10). One
commenter, however, expressed concern that 30 mL is insufficient when
dealing with a specimen that is positive for more than one drug. That may
be the case in some cases. Nevertheless, the number of specimens that are
positive for more than one drug is very small and most volumes collected
generally exceed 30 mL. The Department believes this reduced volume
requirement will make it easier for an individual to provide a urine
specimen with sufficient volume on the first attempt rather than requiring
the collection of a second specimen after drinking a reasonable quantity
of liquid. It is noted that the policy of combining additional urine,
after drinking a reasonable amount of liquid, with a partial specimen
(i.e., an insufficient volume of urine on the first void) has been
eliminated. The Department believes the reduced volume requirements will
ensure that a sufficient volume is collected on the first void and
combining partial specimens will not be necessary.

One commenter expressed concern over the fact that the Mandatory
Guidelines did not specify limitations or guidance as to the amount of
liquid to be given a donor who could not provide a 30 mL urine specimen.
The commenter expressed concerns regarding the possible risk of water
intoxication if there is no limit established for the amount of liquid
that can be provided. The Department concurs and has changed the example
given in section 2.2(f)(10) to read "(e.g., an 8 oz glass of water
every 30 minutes, but not to exceed a maximum of 24 oz)." The example
provided describes a reasonable amount of liquid to be provided and the
Department would expect collection sites to use reasonable care in its
determination of the amount of liquid to provide donors.

Several commenters noted that the temperature range stated in the
proposed revisions did not agree with the range stated in the introductory
discussion of the proposed changes. A notice correcting the error was
published in the Federal Register on March 1, 1993. The correct
temperature range is "32 -38 /90 -100 F."

There was general agreement that the marginally wider temperature range
will not adversely affect the ability to detect a donor who may possibly
tamper with the specimen. Two commenters, however, believe that the lower
limit of the temperature range should be increased. The Department does
not agree with this recommendation. A urine specimen provided in a
collection cup that is at room temperature will cool quickly; therefore, a
narrow temperature range will significantly increase the number of
specimens that will not satisfy the temperature range requirements. This
would cause numerous unnecessary collections of second specimens and
falsely raise suspicions that many donors have tampered with their
specimens.

With regard to the collection of a urine specimen when using direct
observation, one commenter suggested that the employee's agency choose the
observer if there is no collection site person of the same gender
available. The Department agrees and sections 2.2(f)(13), 2.2(f)(16), and
2.2(f)(23) have been revised to include this requirement. The Department
believes that the agency will select an individual who will act
responsibly and reliably so as not to substantiate any allegation to the
contrary by an employee.

One commenter believes that only trained collectors should be involved
in the collection procedure, especially when direct observation is
required. The Department acknowledges that trained personnel should be
involved in the collection of urine specimens; however, it is not always
possible to ensure that a trained collection site person of the same
gender will be available when a direct observation is required. Allowing
the agency to select an individual to act as the observer, when there are
unusual circumstances, ensures that the collection will occur promptly and
as scheduled rather than delaying the collection unnecessarily.

One commenter believed that observed collection should never be used in
any circumstances. The Department disagrees. The Department continues to
believe that observed collection is justified and necessary when there
exists reasonable suspicion to believe that the donor altered or
substituted the specimen. Observed collections do not occur frequently.
However, the Department believes that any invasion of a donor's privacy is
greatly outweighed by public health and safety concerns in such cases.

One commenter recommended that we refer to the individual providing the
urine specimen as the "donor." The Department concurs with the
recommendation and has replaced the word "individual," when it
refers to the person providing a urine specimen, with the word
"donor" throughout the Guidelines. A definition for donor has
been included in section 1.2. In addition, the use of the word
"donor" is consistent with its use on the specimen chain of
custody form.

One commenter suggested that the entire collection procedure be revised
substantially to provide more specific guidance to agencies on the
collection process. The Department believes the procedure, as described,
provides sufficient guidance to the agencies on the collection process,
including factors to ensure that urine specimens are collected properly
and satisfy chain of custody requirements. The changes made in the
Mandatory Guidelines with regard to the single specimen collection
procedure and the optional split specimen procedure should clarify the
procedures and, thereby, address many of the concerns raised by this
commenter without completely revising and expanding the descriptions of
the collection procedures.

Many commenters concurred with including an optional split specimen
collection procedure. They believed it was important to include split
specimens since the Omnibus Transportation Employee Testing Act of 1991,
Title V of Pub. L. 102-143, requires using a split specimen collection
procedure for industries regulated by the Department of Transportation
(DOT). This is particularly important since Federal employees from a
number of Departments will be subject to both the requirements of DOT (49
CFR Part 40) and the requirements of the Mandatory Guidelines and
Executive Order 12564 (September 15, 1986).

Two commenters suggested allowing the use of two or three containers to
collect split specimens. The Department agrees with this recommendation
and has revised the collection procedure to indicate clearly that either a
specimen bottle or a specimen container may be used when collecting urine
specimens. However, when using a split specimen collection procedure, it
is not acceptable for a donor to provide the split specimens by urinating
directly into both Bottle A and Bottle B. The specimen must be provided by
urinating into only one container or into Bottle A. After the temperature
is measured, if the specimen was provided directly into Bottle A, an
appropriate amount is poured into Bottle B. If a specimen container was
used, appropriate amounts are poured from the specimen container into both
Bottle A and Bottle B. For split specimen collections, this procedure
ensures that the specimens in Bottle A and Bottle B are identical, it is
easier to measure the temperature of a single specimen rather than to
measure the temperature of two specimens that were collected in separate
containers, and it is easier for a donor to provide one specimen in a
single container/bottle rather than into two separate bottles. It was
suggested by several commenters that we specify the amount of urine to be
poured into Bottle B. We concur with that recommendation and have changed
section 2.2(h)(3) of the split specimen procedure to specify that a
minimum of 15 mL of urine shall be poured into Bottle B. Since Bottle B
will only be tested for a specific substance(s), 15 mL is sufficient to
conduct the testing and to allow a sufficient quantity to be retained
frozen if Bottle A is reported positive. Additionally, section 2.2(h)(1)
has been changed to specify that a minimum of 45 mL of urine is required
when using a split specimen collection procedure rather than the 30 mL
minimum when using the single specimen collection procedure.

One commenter was concerned with the handling and storage of the split
specimen (Bottle B) after the Bottle A specimen is shipped to the
laboratory. We agree that the wording in section 2.2(h)(5) of the split
specimen collection procedure regarding refrigerating the specimens was
confusing and it has been revised. The Department believes that the most
efficient and cost effective way to handle split specimens is to send both
the Bottle A and Bottle B specimens to the laboratory at the same time
including the appropriate specimen chain of custody forms. This procedure
will ensure the integrity of both Bottle A and Bottle B. This procedure is
also simpler and more cost effective than one which would require the
collection site to retain Bottle B specimens until the results for the
Bottle A specimens are reported by the MRO to the agency and the agency
notifies the collection site to either discard the Bottle B specimens or
to ship a specific Bottle B specimen to another certified laboratory. When
both specimens are received by the laboratory, Bottle A is normally tested
within one day and, if positive, both Bottle A and Bottle B can be placed
in secure, refrigerated storage until the confirmatory test is completed.
This procedure will ensure that both specimens are treated essentially the
same and subject to similar storage conditions until the testing is
completed.

Several commenters were concerned with the impact that a failed to
reconfirm result on the Bottle B specimen would have on a donor since
personnel action may have been taken based on an MRO verified positive
result for Bottle A. Although a failed to reconfirm result for Bottle B
requires the MRO to void the test result for Bottle A and an agency may be
required to reverse any personnel action that may have been taken, we
believe failed to reconfirm reports will occur infrequently and this
possibility should not be the basis for an agency to delay any personnel
action. The Department believes that removing an employee, for example,
from a safety- sensitive position which may impact public health and
safety outweighs the minimal possibility that the testing of Bottle B will
not reconfirm the presence of a drug or metabolite.

In view of the comments, section 2.2(h)(6) has also been clarified to
indicate the MRO's responsibility to report a positive result for Bottle
A. When an MRO has verified the test of the first specimen bottle (Bottle
A) as a positive result, the MRO must report the result to the agency
without waiting for the donor to request that the Bottle B specimen be
tested.

Several commenters expressed concern regarding the actions taken when a
second laboratory fails to reconfirm the presence of a drug or metabolite
in the second specimen bottle (Bottle B) in a split specimen collection.
Since the Bottle B specimen is tested without regard to the cutoff levels,
the result reported by the second laboratory is not reported as a negative
or positive result, but reported as either reconfirmed or failed to
reconfirm the presence of a drug or metabolite. The Department agrees that
if this situation occurs, an investigation must be conducted. The
Department has added this requirement in section 2.2(h)(8) of the
Mandatory Guidelines and has required the MRO to notify the donor's
agency. In addition, the Federal agency must contact the Secretary and the
Secretary will investigate the failed to reconfirm result and attempt to
determine the reason for the inconsistent results between Bottle A and
Bottle B. HHS will report its findings to the Federal agency and ensure
that appropriate action is taken to prevent the recurrence of the failed
to reconfirm result.

Some commenters simply did not like permitting Federal agencies to have
the option of a split specimen procedure, believing, for example, that the
use of a split specimen procedure gives the perception of a lack of
confidence in the results when using a single specimen collection, that
the additional administrative and collection costs are not justified, and
that there is an increased risk of administrative errors.

It should be noted that certain Federal employees are subject to both
the Mandatory Guidelines and the Omnibus Transportation Employee Act of
1991, Title V of Pub. L. 102-431, (Omnibus Act) which requires split
specimens. Therefore, the agencies must have the flexibility to collect
split specimens as required by the Omnibus Act. Since Federal agencies may
also request a waiver under section 1.1(e) of the Mandatory Guidelines and
the Department has provided a number of agencies with a waiver to permit
split specimens during the past 5 years, the Department believes including
an optional split specimen collection procedure in the Mandatory
Guidelines will ensure consistency among all agencies currently using
split specimens and those wanting to implement split specimen collections.
In addition, each agency should have the option of treating its employees
equally rather than treating its employees under the Omnibus Act
differently from the employees only subject to the Mandatory Guidelines.

With regard to the perception that the results from a single specimen
collection are unreliable and not adequate to protect employee rights when
compared to a split specimen collection, the Department is confident that
the results from a single specimen collection are scientifically and
legally supportable. This belief is based on the stringent requirements
that have been established by the Mandatory Guidelines -- that is,
requiring the use of rigorous chain of custody procedures when handling
and testing specimens; requiring laboratories to use qualified and trained
personnel, validated analytical testing procedures, and extensive internal
quality control and quality assurance procedures; requiring laboratories
to participate in a comprehensive certification program that includes
performance testing samples and semi-annual inspections; and using MROs to
ensure that procedures have been followed as required.

Although the split specimen procedures are designed to minimize
administrative errors, the Department acknowledges that any time
procedures are modified the risk of administrative errors increases.
However, the use of a standard specimen chain of custody form should
minimize such errors and the Department, through the inspection process,
will monitor the laboratories' procedures in processing split specimens.

The procedures for split specimens are also designed to keep the
administrative burden at a minimum. The Department believes that the
paperwork for collection sites or laboratories will not increase much
since the collection sites will be using a seven-part chain of custody
form instead of a six-part form and sending both split specimens to the
laboratory at the same time and in the same shipping container. This
should minimize the additional cost and administrative burden on both
collection sites and laboratories.

One commenter believed that split specimen collections create a
potential to reverse results especially if there is a significant
variation in the analytical sensitivities of the confirmatory tests used
by each of the HHS-certified laboratories. The Department is aware of this
potential and has provided guidance to the laboratories with regard to
their capability to accurately quantitate and identify drugs at
concentrations that are 40 percent of the confirmatory test levels. The
Department believes this guidance and challenging laboratories with
performance testing samples at these low concentrations will ensure that
all laboratories have essentially the same sensitivity for each of the
confirmatory tests.

Finally, one commenter requested guidance on whether the donor or
agency would be responsible for paying the costs associated with analyzing
the split specimen. The Department believes that the decision regarding
financial responsibility for testing Bottle B is one the agencies must
decide.

4. Certifying Test Results

One commenter stated that the proposed revision to section 2.3(b) that
discusses "test validation" did not make it clear that a
laboratory may use a certifying scientist who is only certified to review
initial drug tests which are negative. Although this is the intent of this
section and to ensure that no confusion exists, the title of section
2.3(b) has been changed to read "Certifying Test Results" and
that section has been revised to state clearly that a laboratory may
designate a certifying scientist(s) that is only qualified to certify
results that are negative on the initial test. We note, however, that if a
certifying scientist certifies confirmatory test results, the individual
must have training and experience in all "procedures relevant to the
results that the individual certifies." This includes both initial
test and confirmatory test procedures. Changing the title of this section
to read "Certifying Test Results" should also ensure that we are
referring to the review and certification of specimen test results rather
than the results associated with "validating" an analytical
procedure before it is used to test specimens. The Department believes
there was some confusion associated with the former title of this section.

5. Security and Chain of Custody

One commenter requested that the security requirements in section
2.4(a)(1), as proposed, be revised to allow emergency personnel access to
all sections of the laboratory without escorts. The requirements for
security pertain to limiting and documenting access under normal
situations and providing escorts for authorized visitors, maintenance, and
service personnel. For real emergencies, such as fires, it would be
inappropriate to require the laboratory to provide an escort. This section
has been changed to ensure that emergency personnel (such as firefighters)
can have unescorted access similar to that authorized for inspectors. As
suggested by the commenter, it would be acceptable for the laboratory to
document the emergency and include, to the extent practicable, dates, time
of entry and exit, and purpose of entry for all emergency response
personnel. It must be noted that this exception does not apply to
emergency "service" personnel, such as manufacturers' technical
representatives who are called to repair an instrument or to conduct
routine service.

6. Specimen Processing

One commenter noted that the word "standards" had been used
incorrectly in section 2.4(d), as proposed, when stating the requirements
for each initial and confirmatory batch. The Department concurs and has
changed this section to state that each initial and confirmatory batch
must satisfy the quality control requirements in sections 2.5(b) and
2.5(c), respectively, rather than using terms such as
"standards" and "controls." Additionally, the last
sentence of this section has been deleted because it is not entirely
correct. Quality control samples must be known to laboratory technicians
conducting the testing while only blind performance testing samples are
unknown (i.e., the location in the batch, drug or metabolite present, and
concentration). The requirements for laboratory blind performance testing
samples and agency blind samples are discussed in section 2.5.

7. Marijuana Initial Test Level

Many respondents concurred with lowering the initial test level for
marijuana metabolites from 100 to 50 ng/mL as proposed in section 2.4(e).
However, one commenter claimed that the lowered cutoff concentration would
identify the occasional user. The intent of Federal Workplace drug testing
programs is to identify individuals who use illegal substances regardless
of whether they are regular or occasional users. Lowering the initial test
level should increase the ability to detect any use of marijuana.

Another commenter questioned the impact that might result by the
lowered cutoff concentration for those individuals who are exposed to
passive inhalation (i.e., breathing the smoke exhaled by another
individual smoking marijuana cigarettes). The Department does not believe
that passive inhalation is a reasonable defense or that significant
exposure can occur through passive inhalation to cause a urine specimen to
be reported positive. A comprehensive study of passive inhalation
conducted at the National Institute on Drug Abuse's Addiction Research
Center in Baltimore (see Cone, E.J., et al., Passive Inhalation of
Marijuana Smoke: Urinalysis and Room Air Levels of
Delta-9-Tetrahydrocannabinol, Journal of Analytical Toxicology, 11: 89-96,
1987) indicates that it takes extensive exposure to extremely high
concentrations under unrealistic conditions to cause a positive result;
therefore, passive inhalation is not a reasonable explanation for a
positive result.

8. Initial and Confirmatory Tests

One commenter believed that the wording in section 2.4(e)(3), as
proposed, conflicted with the authority to conduct dilution/adulteration
tests as stated in section 2.1(c). The Department agrees that this section
needs to be clarified. A laboratory may conduct dilution/adulteration
tests on all specimens, whether they are positive or negative, and either
before or after conducting the initial test. Section 2.4(e)(3) has been
changed to clarify this policy.

Several commenters questioned the use of specimens that test negative
on either the initial test or the confirmatory test for the laboratory's
internal quality control program as proposed in sections 2.4(e)(3) and
2.4(f)(3). These commenters were concerned that the results may have been
affected by such factors as medications that may have been taken, the
health of the donors, and possible unknown problems with confirmation,
thereby, making these specimens unsuitable as quality control samples.
Several of these commenters recommended the use of certified negative
urine or, at a minimum, confirming the negative pool by GC/MS prior to its
use in a quality control program. In response to these concerns, the
Department notes that the laboratory's operation must be consistent with
good forensic laboratory practice (see section 3.20(c)) and such practice
requires a laboratory to always certify a urine pool as negative before it
is used to prepare negative samples or to prepare other quality control
samples. If pooled urine does not satisfy the criteria for acceptability,
it is discarded. Such certification of the urine will ensure the quality
of a laboratory's internal quality control program.

9. Multiple Initial Tests

Two commenters supported the use of multiple initial tests as stated in
section 2.4(e)(4), as proposed, while several commenters expressed concern
with permitting the use of multiple testing. The Department believes that
the use of multiple initial tests may reduce the number of presumptive
positives that are forwarded to confirmatory testing that will not be
confirmed and may allow obtaining a valid analytical result if a specimen
is untestable on one immunoassay test.

The use of multiple initial tests has been widely used with regard to
testing for amphetamines and this policy should apply to all drugs.

In addition, there are reports that various substances, including
prescription medications, can prevent obtaining a valid initial test
result when using one immunoassay test. We believe it is appropriate to
use a different immunoassay test in order to obtain a valid initial test
result before reporting the specimen as "test not performed" and
including an appropriate comment on the specimen chain of custody form. To
clarify this issue, the example given in section 2.4(e)(4) has been
changed to include the use of a second immunoassay test for untestable
specimens. It is noted that the last sentence of section 2.4(e)(4), as
proposed, has been deleted since it is redundant with the requirements as
stated in the first sentence of the section.

10. 200 ng/mL Amphetamine Reporting Rule

Six commenters concurred with the proposal in sections 2.4(f)(1) and
2.4(g)(2) that require a methamphetamine positive to contain at least 200
ng/mL of amphetamine before reporting the result as positive. Two
commenters recommended that the 200 ng/mL rule be dropped entirely because
they believed it is no longer relevant and the emphasis should be on
improving the quality of the GC/MS confirmatory procedure. Seven
commenters held similar views that the 200 ng/mL rule is too conservative
and produces too many false negatives and recommended that it be lowered
to either 100 or 50 ng/mL or at least equal to or greater than the limit
of detection for amphetamine.

The Department believes that the 200 ng/mL requirement implemented as a
temporary policy since December 22, 1990, is a necessary one to prevent
false positive test results. On a special set of performance testing
samples provided to the laboratories by the program, the Department found
that the requirement adequately controlled all of the possible technical
problems based on observations of results reported by the laboratories on
that set of performance testing samples. The results indicated that a
significant number of laboratories experienced chromatographic resolution
problems when methamphetamine was present with ephedrine and 2% of the
performance testing results evidenced a methamphetamine response when
challenged with high concentrations of over-the-counter medications (e.g.,
ephedrine, pseudoephedrine, or phenylpropanolamine). These results
indicated that the 200 ng/mL rule was effective in preventing any false
positive results and should be continued. In addition, recent information
provided by laboratories regarding their limits of quantitation and their
results on performance testing samples that contained very low
concentrations of amphetamine and methamphetamine indicate that 200 ng/mL
continues to be the lowest concentration that most of the laboratories can
reliably identify and quantitate for either methamphetamine or
amphetamine. For these reasons, the Department believes using a lower
concentration or eliminating the 200 ng/mL rule would increase the
possibility for reporting a false positive methamphetamine result.

11. Reporting Results

One commenter was concerned that substituting "certifying
scientist" in section 2.4(g)(5), as proposed, for the responsible
person was making the certifying scientist responsible for the overall
laboratory operations. We believe the commenter did not understand the
purpose for changing the wording in this section. The use of
"certifying scientist" in this section ensures that the
requirement is consistent with current program practice. The responsible
person continues to be responsible for the overall operation of the
laboratory (see section 2.3(a)); however, section 2.4(g)(5) allows a
certifying scientist to sign the external chain of custody form that is
sent to the MRO.

12. Calibrators and Controls

One commenter raised concern with the materials used to prepare
calibrators and controls which as described in section 2.4(n)(2) only
allowed calibrators and controls to be prepared from pure drug standards.
The commenter correctly indicated that calibrators and controls were
available from other sources. The Department concurs and has revised the
sentence to allow calibrators and controls to be prepared not only from
pure drug reference materials, but from stock standard solutions obtained
from other laboratories, or from commercial manufacturers. This change
clarifies that laboratories have the flexibility to obtain
"standards" used to prepare the calibrators and controls from
different sources.

13. Potential Conflicts of Interest

Several commenters supported the policies in sections 2.4(n)(6) and
2.6(b), as proposed, that restricts the types of relationships between
laboratories and Medical Review Officers to ensure there were no conflicts
of interest. There were several comments submitted, however, stating that
these requirements were not necessary since there is no evidence that MROs
have not acted in the interest of the donor or that current arrangements
have adversely affected the ability of an MRO to monitor laboratories. The
Department does not question the dedication and integrity of its certified
laboratories and the MROs in carrying out their responsibilities and
protecting the interests of the Federal agencies and donors. Nevertheless,
the Department believes the issue must be addressed.

The MRO plays an essential role in the Federal drug testing program.
See generally section 2.6 of the Mandatory Guidelines. The MRO is a
licensed physician with a knowledge of substance abuse disorders who
verifies whether the tests are positive or negative. In the case of a
positive result reported by the laboratory, the Mandatory Guidelines
require that the MRO contact the employee and personally interview the
employee, i.e., in-person or by telephone, to determine whether alternate
medical explanations would explain a positive result. See section 2.6(c).
During the course of such interview and possibly through having the
specimen retested, the MRO may identify false positive test results. In
such a case, the MRO is required to contact the Secretary so that the
Department can conduct an investigation into the matter and take whatever
action is necessary to prevent such a result from occurring in the future.
See section 2.6(g). Because the MRO plays such an essential role, the
Department believes any relationship that may be construed as a potential
conflict of interest may be sufficient to undermine the integrity of the
program. Every Federal agency, employee, and job applicant must have
complete assurance that test results will be thoroughly reviewed and, if
errors are discovered, that the MRO will report the error and an
appropriate investigation and corrective action will be taken.

14. Laboratory Quality Control Requirements for Initial Tests

There were several comments submitted regarding the requirements in
section 2.5(b), as proposed, for quality control samples when conducting
the initial test. The commenters believed the proposed requirements were
confusing and suggested using different terms to describe the types of
quality controls that must be included in each initial test batch. The
Department concurs that the quality control requirements in this section
were confusing and they have been revised based on the definitions in
section 1.2. It should be noted the changes to this section only clarify
the requirements for quality control samples; the actual policy has not
changed from the original Mandatory Guidelines. See section 2.5(b) of 53
FR 11979, 11984 (April 11, 1988). We have also revised the quality control
requirements for each confirmatory test batch in section 2.5(c) using the
new definitions in section 1.2 without changing the policy as compared to
the original Mandatory Guidelines. See section 2.5(c) of 53 FR 11979,
11985 (April 11, 1988).

In addition, it was noted that there was an error in the requirement
that each initial test batch must contain a minimum of 20% quality control
samples. A correction stating that 10% was the minimum amount was
published in the Federal Register on March 1, 1993.

15. Agency Blind Sample Program

A number of commenters supported reducing the requirements for agency
blind samples from 10% to 3% as indicated in section 2.5(d)(2). One
commenter suggested retaining the 10% minimum and one commenter suggested
establishing a minimum number of blind samples per quarter for
organizations with a small test population. The Department believes the
reduced requirement will not have a significant impact on the ability of
an agency to evaluate its entire drug testing program; however, there is
no prohibition for an agency to use a higher percentage or a higher number
of blind samples to be submitted with donor specimens.

The Department has also changed the requirements for the number of
blind samples to be submitted with donor specimens during the initial
90-day period of any new contract to conform with reducing the
requirements of blind samples as provided by section 2.5(d)(2). Our
experience during the past 5 years suggests that it is not necessary to
submit large numbers of blind samples to verify the testing conducted by
the certified laboratories.

16. Reanalysis Authorized

Two commenters expressed concern with the retesting policy proposed in
section 2.6(e) which provided that only the MRO was authorized to order a
reanalysis of the original specimen or Bottle B from a split specimen
collection. One commenter believes the donor was authorized to request a
retest of the original specimen. It is the Department's position that if
an MRO cannot verify a positive result for whatever reason, only the MRO
is authorized to request the retest of the original specimen since the MRO
is the only individual who has all the information necessary to identify a
particular specimen in a laboratory.

Another commenter pointed out an inconsistency between the retest
policy proposed in this section and the policy proposed for testing Bottle
B from a split specimen collection as described in section 2.2(h)(6) which
states that only the donor may request through the MRO that the second
specimen bottle (Bottle B) be tested. The Department agrees that there is
an inconsistency in the proposed policies because we inadvertently
referred to the Bottle B specimen in section 2.6(e) rather than the Bottle
A specimen. Section 2.6(e) has been changed to clarify that only the MRO
may request the retest of either a single specimen or a Bottle A specimen
when using a split specimen collection. The procedures for the testing of
Bottle B remain as proposed in section 2.2(h)(6) -- that is, only the
donor may request through the MRO that Bottle B be tested.

17. Reporting Final Results to the Agency

One commenter suggested that section 2.6(h), as proposed, which
clarifies the requirement that the MRO provide written reports to the
agency on positive and negative drug test results would significantly
increase the administrative costs associated with the program and
recommended that the MRO be required to provide written reports to the
agency for positive results only. The Department disagrees. Written
reports from the MRO to the agency on all specimens tested ensures that
all specimens have been tested and the results of all specimens have been
reviewed by the MRO. In addition, the Department believes that this
requirement for written reports to the agency does not prevent the MRO
from reporting several results on the same correspondence sent to the
agency and, therefore, should not significantly affect the cost associated
with the MRO review of drug testing results.

18. Certified Laboratories Notifying Private Sector Clients

Two commenters were concerned that the policy in section 3.4 did not
adequately ensure that a laboratory would inform clients if and when the
laboratory did not satisfy the certification requirements. The Department
concurs that a laboratory must inform its clients when its certification
has been suspended. Since the program began, this notification has been
required and is set out in the suspension letter that is sent to the
laboratory.

However, the intent of the requirement in section 3.4 that certified
laboratories clearly inform clients when procedures followed do not
conform to the Mandatory Guidelines is not related to suspension and/or
proposed revocation actions. The purpose is to ensure that unregulated,
private sector clients are aware that the laboratory may be using
procedures that are not subject to or in accordance with the Mandatory
Guidelines. The Department believes that a certified laboratory must not
use its certification to promote itself as such if, in fact, it uses
procedures that do not comply with the Mandatory Guidelines for such
clients. This section has been revised to clarify this requirement.

19. Performance Testing Program

There were several comments submitted regarding changing the
performance testing (PT) program from a bimonthly program to a quarterly
program as stated in various sections of subpart C. One commenter
disagreed with changing the performance testing program to a quarterly
program because this would prolong the recertification process and
suggested that a monthly PT program would be more appropriate. The
Department has no intention of changing the initial certification
procedures or to change the procedures when a laboratory has been
suspended and must successfully analyze performance testing samples prior
to having the suspension lifted. In addition, the Department believes a
monthly PT program does not allow sufficient time for a laboratory to
receive its results on a set of PT samples, analyze its performance, and
initiate appropriate corrective action before the next cycle of PT
samples.

One commenter was concerned that adopting a quarterly PT program
without changing the criteria for determining acceptable performance, as
set out in section 3.19, would increase the period for evaluating a
laboratory's performance to 9 months. The Department concurs that the
criteria for determining acceptable performance, that is, performance on 3
consecutive quarterly PT cycles, would unduly lengthen the time before
corrective action may be taken. Since the total number of PT samples in 2
cycles of the quarterly PT program will be essentially the same as those
for 3 cycles of the bimonthly PT program, it is appropriate to establish
acceptable performance criteria based on performance over 2 consecutive
cycles of quarterly PT samples. All criteria in section 3.19 that pertain
to evaluating the performance of certified laboratories have been changed
to evaluate acceptable performance over 2 consecutive cycles rather than
over 3 consecutive cycles, which retains the 6-month evaluation period.

One commenter agreed with the change in section 3.19(b)(4), as
proposed, that would allow a certified laboratory to have one quantitative
result greater than 50% from the target value without requiring program
action against the laboratory. However, the commenter is concerned that
the cause for the error may not be investigated since program action is
not taken against the laboratory. The Department did not intend that this
change would prevent any investigation into the cause for the error or
that the laboratory would not be required by the Department to make a
concerted effort to determine the cause for the error and to take
appropriate corrective action. One commenter believes that the overall
costs for the certification program may be decreased without compromising
the high quality of the program by increasing the PT challenges to a
monthly program and decreasing the maintenance inspections to once a year.
The Department disagrees with this proposal because it is important to
inspect laboratories at least every six months to ensure that the
laboratory has continued to satisfy the requirements of the Mandatory
Guidelines and for the inspectors to review the results reported for the
PT samples. If corrective action is necessary, it will be more timely than
if inspections were on a yearly basis. In addition, the existence of a
significant problem over a long period of time would possibly jeopardize
the results of many more personnel specimens.

20. Corrective Action by Certified Laboratories

Several commenters expressed concern that section 3.12(c), as proposed,
would give the Secretary the authority to review all results and
activities associated with a laboratory's testing of specimens for private
sector, unregulated clients. This was not the intent and the section has
been changed to indicate that the Secretary has authority to review
results for specimens collected for private sector clients that were
tested by the certified laboratory under the Mandatory Guidelines to the
extent necessary to ensure the full reliability of drug testing for
Federal agencies.

21. Recertification

One commenter was concerned with the policy contained in section 3.16,
as proposed, because the commenter believed the procedure to regain
certification after the laboratory's certification has been revoked would
be prolonged given that the maintenance PT program has been reduced to a
quarterly program. The commenter misunderstood that provision. The
Department has not changed the initial certification procedure (section
3.16) under which a laboratory that had its certification revoked must
proceed to regain certification. Thus, such a laboratory will proceed as
in the past and must satisfactorily perform in each phase of the initial
certification process. However, the first sentence of section 3.16 has
been changed to indicate that the recertification policy applies only when
a laboratory has its certification revoked.

22. Inspection Performance

One commenter was concerned that the meaning of the phrase
"consistent with good forensic laboratory practice" in section
3.20(c), as proposed, was too subjective. The commenter believes that each
inspection team interprets laboratory's procedures differently, thereby,
what is acceptable during one inspection may be unacceptable during the
next inspection. We do not concur with this assessment of the inspection
process. Although there is some inherent subjectivity in the inspection
process when applying certain criteria under the Mandatory Guidelines, the
inspectors are provided clear guidance on what is to be inspected and what
is acceptable and unacceptable. The Department requires trained, qualified
inspectors to use a comprehensive checklist consisting of some 300
questions to evaluate a laboratory's procedures. They are asked to respond
"yes" or "no" to the questions and then provide
comments if the answer is unacceptable. This checklist ensures that each
inspector is reviewing essentially all of the same laboratory documents
and results. The inspection reports are reviewed by the Department to
ensure that program requirements and policies are applied consistently
among all laboratories. In addition, it is the responsibility of each
laboratory to review the Mandatory Guidelines, to be aware of what is to
be inspected by reviewing the checklist and other program documents, to
correct deficiencies, and to use good forensic laboratory practice in its
testing program.

One commenter suggested that the word "all" be deleted from
the second sentence in section 3.20(c), as proposed, because a laboratory
is not required to correct "all" deficiencies identified by the
inspectors. We concur with the comment and have deleted the word
"all." The Department's policy has always been to include minor
deficiencies or concerns in the critique developed from the inspection
reports and give the laboratory the option to take whatever additional
corrective action it deems appropriate for these minor deficiencies or
concerns.

23. Procedures for Review of Suspension or Proposed Revocation of a
Certified Laboratory

One commenter suggests that the definition of appellant in section 4.2,
as proposed, is unclear and believes that the review procedures only apply
when there is a proposed revocation. The Department disagrees with this
position. The Department believes that principles of fairness necessitate
allowing laboratories to seek internal reviews not only of proposed
revocations but also internal reviews of immediate suspensions.

24. Other Minor Changes

In addition to the changes discussed above, there were several minor
changes made in other sections. The acronym "MRO" has been added
to the definition for Medical Review Officer in section 1.2. Since the
original Guidelines were published, the "MRO" acronym has become
a common and accepted way to refer to a physician performing this
function. We have replaced "Medical Review Officer" with
"MRO" throughout the Guidelines.

Section 2.5(d)(4) was changed to clarify that an agency shall
investigate any unsatisfactory blind performance testing results and
submit its findings to HHS rather than HHS conducting the initial
investigation. The Department believes the agency must gather all
pertinent information and investigate the reason before HHS is contacted
to continue the investigation and to ensure that the laboratory has taken
corrective action.

Section 2.6(c) has been simplified to require the MRO to send results
only to the designated person in the agency rather than to both agency's
Employee Assistance Program and to the agency's management official. The
Department believes that the agency should have the discretion to
determine who should receive results.

Section 3.3 was clarified to read that a laboratory must satisfy all
pertinent provisions of the Guidelines in order to maintain certification
while the original requirement only addressed satisfying the provisions in
order to qualify for certification.

Section 3.15(b) was revised to conform with the review procedure in new
subpart D which allows laboratories the opportunity for an informal review
of a program action within 30 days of the date the laboratory received the
notice, or if seeking an expedited review, within 3 days of the date the
laboratory received the notice.

Two commenters noted that section 3.18(b) referred to a subset of PT
samples as "directed specimens" rather than as "retest
samples" which is current program terminology. We concur with the
comment submitted and have revised the section to refer to these PT
samples as "retest samples."

Other appropriate minor editorial changes have been made for clarity
and consistency.

Information Collection Requirements

Any comments related to the Paperwork Reduction Act of 1980 may be sent
to the HHS Desk Officer, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 3001, New Executive Office Building,
Washington, D.C. 20503. Information collection and recordkeeping
requirements which would be imposed on laboratories engaged in urine drug
testing for Federal agencies concern quality assurance and quality
control; security and chain of custody; documentation; reports;
performance testing; and inspections as set out in sections 3.7, 3.8,
3.10, 3.11, 3.17, and 3.20. To facilitate ease of use and uniform
reporting, a specimen chain of custody form has been developed as
referenced in sections 1.2, 2.2(c), and 2.2(f).

The information collection and recordkeeping requirements contained in
these Mandatory Guidelines have been submitted to the Office of Management
and Budget for review under section 3504(h) of the Paperwork Reduction Act
of 1980.

Dated: February 7, 1994

Philip R. Lee
Assistant Secretary for Health

Dated: March 16, 1994

Donna E. Shalala
Secretary

The Mandatory Guidelines as revised are hereby adopted in accordance
with Executive Order 12564 and section 503 of Pub. L. 100-71. For the
public's convenience the Mandatory Guidelines as revised are set out in
full as follows:

(3) And any other employing unit or authority of the Federal Government
except the United States Postal Service, the Postal Rate Commission, and
employing units or authorities in the Judicial and Legislative Branches.

(b) Subpart C of these Guidelines (which establishes laboratory
certification standards) applies to any laboratory which has or seeks
certification to perform urine drug testing for Federal agencies under a
drug testing program conducted under E.O. 12564. Only laboratories
certified under these standards are authorized to perform urine drug
testing for Federal agencies.

(c) The Intelligence Community, as defined by Executive Order No.
12333, shall be subject to these Guidelines only to the extent agreed to
by the head of the affected agency.

(d) These Guidelines do not apply to drug testing conducted under legal
authority other than E.O. 12564, including testing of persons in the
criminal justice system, such as arrestees, detainees, probationers,
incarcerated persons, or parolees.

(e) Agencies may not deviate from the provisions of these Guidelines
without the written approval of the Secretary. In requesting approval for
a deviation, an agency must petition the Secretary in writing and describe
the specific provision or provisions for which a deviation is sought and
the rationale therefor. The Secretary may approve the request upon a
finding of good
cause as determined by the Secretary.

(f) Agencies shall purchase drug testing services only from
laboratories certified by HHS or an HHS-recognized certification program
in accordance with these Guidelines.

Section 1.2 Definitions.

For purposes of these Guidelines the following definitions are adopted:
Aliquot A fractional part of a specimen used for testing. It is taken as a
sample representing the whole specimen.

Calibrator A solution of known concentration used to calibrate a
measurement procedure or to compare the response obtained with the
response of a test specimen/sample. The concentration of the analyte of
interest in the calibrator is known within limits ascertained during its
preparation. Calibrators may be used to establish a calibration curve over
a range of interest. Certifying Scientist An individual with at least a
bachelor's degree in the chemical or biological sciences or medical
technology or equivalent who reviews all pertinent data and quality
control results. The individual shall have training and experience in the
theory and practice of all methods and procedures used in the laboratory,
including a thorough understanding of chain of custody procedures, quality
control practices, and analytical procedures relevant to the results that
the individual certifies. Relevant training and experience shall also
include the review, interpretation, and reporting of test results;
maintenance of chain of custody; and proper remedial action to be taken in
response to test systems being out of control-limits or detecting aberrant
test or quality control results.

Chain of Custody Procedures to account for the integrity of each
urine specimen by tracking its handling and storage from point of specimen
collection to final disposition of the specimen. These procedures shall
require that an Office of Management and Budget (OMB) approved specimen
chain of custody form be used from time of collection to receipt by the
laboratory and that upon receipt by the laboratory an appropriate
laboratory chain of custody form(s) account for the specimens and samples
within the laboratory. Chain of custody forms shall, at a minimum, include
an entry documenting date and purpose each time a specimen or sample is
handled or transferred and identifying every individual in the chain of
custody. Collection Site A place designated by the agency where
individuals present themselves for the purpose of providing a specimen of
their urine to be analyzed for the presence of drugs. Collection Site
Person A person who instructs and assists individuals at a collection site
and who receives and makes an initial examination of the urine specimen
provided by those individuals. A collection site person shall have
successfully completed training to carry out this function.

Confirmatory Test A second analytical procedure to identify the
presence of a specific drug or metabolite which is independent of the
initial test and which uses a different technique and chemical principle
from that of the initial test in order to ensure reliability and accuracy.
(At this time gas chromatography/mass spectrometry (GC/MS) is the only
authorized confirmation method for cocaine, marijuana, opiates,
amphetamines, and phencyclidine.) Control A sample used to monitor the
status of an analysis to maintain its performance within desired limits.

Donor The individual from whom a urine specimen is collected.
Initial Test (also known as Screening Test) An immunoassay test to
eliminate "negative" urine specimens from further consideration
and to identify the presumptively positive specimens that require
confirmation or further testing.

Laboratory Chain of Custody Form The form(s) used by the testing
laboratory to document the security of the specimen and all aliquots of
the specimens during testing and storage by the laboratory. The form,
which may account for an entire laboratory test batch, shall include the
names and signatures of all individuals who accessed the specimens or
aliquots and the date and purpose of the access.

Medical Review Officer (MRO) A licensed physician responsible
for receiving laboratory results generated by an agency's drug testing
program who has knowledge of substance abuse disorders and has appropriate
medical training to interpret and evaluate an individual's positive test
result together with his or her medical history and any other relevant
biomedical information. Quality Control Sample A sample used to evaluate
whether or not the analytical procedure is operating within predefined
tolerance limits. Calibrators, controls, negative urine samples, and blind
samples are collectively referred to as "quality control
samples" and each as a "sample."

Reason to Believe Reason to believe that a particular individual
may alter or substitute the urine specimen as provided in section 4(c) of
E.O. 12564. Sample A representative portion of a urine specimen or quality
control sample used for testing.

Secretary The Secretary of Health and Human Services or the
Secretary's designee. The Secretary's designee may be a contractor or
other recognized organization which acts on behalf of the Secretary in
implementing these Guidelines.

Specimen The portion of urine that is collected from a donor.

Specimen Chain of Custody Form An OMB approved form used to
document the security of the specimen from time of collection until
receipt by the laboratory. This form, at a minimum, shall include specimen
identifying information, date and location of collection, name and
signature of collector, name of testing laboratory, and the names and
signatures of all individuals who had custody of the specimen from time of
collection until the specimen was prepared for shipment to the laboratory.

Standard A reference material of known purity or a solution
containing a reference material at a known concentration.

Section 1.3 Future Revisions.

In order to ensure the full reliability and accuracy of drug assays,
the accurate reporting of test results, and the integrity and efficacy of
Federal drug testing programs, the Secretary may make changes to these
Guidelines to reflect improvements in the available science and
technology. These changes will be published in final as a notice in the
Federal Register.

Subpart B - Scientific and Technical Requirements

Section 2.1 The Drugs.

(a) The President's Executive Order 12564 defines "illegal
drugs" as those included in Schedule I or II of the Controlled
Substances Act (CSA), but not when used pursuant to a valid prescription
or when used as otherwise authorized by law. Hundreds of drugs are covered
under Schedule I and II and while it is not feasible to test routinely for
all of them, Federal drug testing programs shall test for drugs as
follows:

(2) Federal agency applicant and random drug testing programs are also
authorized to test for opiates, amphetamines, and phencyclidine; and

(3) When conducting reasonable suspicion, accident, or unsafe practice
testing, a Federal agency may test for any drug listed in Schedule I or II
of the CSA.

(b) Any agency covered by these guidelines shall petition the Secretary
in writing for approval to include in its testing protocols any drugs (or
classes of drugs) not listed for Federal agency testing in paragraph (a)
of this section. Such approval shall be limited to the use of the
appropriate science and technology and shall not otherwise limit agency
discretion to test for any drugs covered under Schedule I or II of the
CSA.

(c) Urine specimens collected pursuant to Executive Order 12564, Pub.
L. 100-71, and these Guidelines shall be used only to test for those drugs
included in agency Drug-Free Workplace plans and may not be used to
conduct any other analysis or test unless otherwise authorized by law
except if additional testing is required to determine the validity of the
specimen. Urine that tests negative by initial or confirmatory testing
may, however, be pooled for use in the laboratory's internal quality
control program.

(d) These Guidelines are not intended to limit any agency which is
specifically authorized by law to include additional categories of drugs
in the drug testing of its own employees or employees in its regulated
industries.

Section 2.2 Specimen Collection Procedures.

(a) Designation of Collection Site. Each agency drug testing
program shall have one or more designated collection sites which have all
necessary personnel, materials, equipment, facilities, and supervision to
provide for the collection, security, temporary storage, and shipping or
transportation of urine specimens to a certified drug testing laboratory.

(b) Security. Procedures shall provide for the designated
collection site to be secure. If a collection site facility is dedicated
solely to urine collection, it shall be secure at all times. If a facility
cannot be dedicated solely to drug testing, the portion of the facility
used for testing shall be secured during drug testing.

(c) Chain of Custody. Chain of custody standardized forms shall
be properly executed by authorized collection site personnel upon receipt
of specimens. Handling and transportation of urine specimens from one
authorized individual or place to another shall always be accomplished
through chain of custody procedures. Every effort shall be made to
minimize the number of persons handling specimens.

(d) Access to Authorized Personnel Only. No unauthorized
personnel shall be permitted in any part of the designated collection site
when urine specimens are collected or stored.

(e) Privacy. Procedures for collecting urine specimens shall
allow individual privacy unless there is reason to believe that a
particular donor may alter or substitute the specimen to be provided.

(f) Integrity and Identity of Specimen. Agencies shall take
precautions to ensure that a urine specimen not be adulterated or diluted
during the collection procedure and that information on the urine bottle
and on the specimen chain of custody form can identify the donor from whom
the specimen was collected. The following minimum precautions shall be
taken to ensure that unadulterated specimens are obtained and correctly
identified:

(1) To deter the dilution of specimens at the collection site, toilet
bluing agents shall be placed in toilet tanks wherever possible, so the
reservoir of water in the toilet bowl always remains blue. There shall be
no other source of water (e.g., no shower or sink) in the enclosure where
urination occurs.

(2) When a donor arrives at the collection site, the collection site
person shall request the donor to present photo identification. If the
donor does not have proper photo identification, the collection site
person shall contact the supervisor of the donor, the coordinator of the
drug testing program, or any other agency official who can positively
identify the donor. If the donor's identity cannot be established, the
collection site person shall not proceed with the collection.

(3) If the donor fails to arrive at the assigned time, the collection
site person shall contact the appropriate authority to obtain guidance on
the action to be taken.

(4) The collection site person shall ask the donor to remove any
unnecessary outer garments such as a coat or jacket that might conceal
items or substances that could be used to tamper with or adulterate the
donor's urine specimen. The collection site person shall ensure that all
personal belongings such as a purse or briefcase remain with the outer
garments. The donor may retain his or her wallet.

(5) The donor shall be instructed to wash and dry his or her hands
prior to urination.

(6) After washing hands, the donor shall remain in the presence of the
collection site person and shall not have access to any water fountain,
faucet, soap dispenser, cleaning agent, or any other materials which could
be used to adulterate the specimen.

(7) The collection site person shall give the donor a clean specimen
bottle or specimen container. The donor may provide his/her specimen in
the privacy of a stall or otherwise partitioned area that allows for
individual privacy.

(8) The collection site person shall note any unusual behavior or
appearance on the specimen chain of custody form.

(9) In the exceptional event that an agency-designated collection site
is not accessible and there is an immediate requirement for specimen
collection (e.g., an accident investigation), a public rest room may be
used according to the following procedures: A person of the same gender as
the donor shall accompany the donor into the public rest room which shall
be made secure during the collection procedure. If possible, a toilet
bluing agent shall be placed in the bowl and any accessible toilet tank.
The collection site person shall remain in the rest room, but outside the
stall, until the specimen is collected. If no bluing agent is available to
deter specimen dilution, the collection site person shall instruct the
donor not to flush the toilet until the specimen is delivered to the
collection site person. After the collection site person has possession of
the specimen, the donor will be instructed to flush the toilet and to
participate with the collection site person in completing the chain of
custody procedures.

(10) Upon receiving the specimen from the donor, the collection site
person shall determine the volume of urine in the specimen
bottle/container.

(i) If the volume is greater than 30 milliliters (mL), the collection
site person will proceed with step (11) below.

(ii) If the volume is less than 30 mL and the temperature is within the
acceptable range specified in step (13) below, the specimen is discarded
and a second specimen shall be collected. The donor may be given a
reasonable amount of liquid to drink for this purpose (e.g., an 8 oz glass
of water every 30 min, but not to exceed a maximum of 24 oz). If the donor
fails for any reason to provide 30 mL of urine for the second specimen
collected, the collection site person shall contact the appropriate
authority to obtain guidance on the action to be taken.

(iii) If the volume is less than 30 mL and the temperature is outside
the acceptable range specified in step (13) below, a second specimen shall
be collected using the procedure specified in step (13) below.

(11) After the specimen has been provided and submitted to the
collection site person, the donor shall be allowed to wash his or her
hands.

(12) Immediately after the specimen is collected, the collection site
person shall measure only the temperature of the specimen. The temperature
measuring device used must accurately reflect the temperature of the
specimen and not contaminate the specimen. The time from urination to
temperature measurement is critical and in no case shall exceed 4 minutes.

(13) If the temperature of the specimen is outside the range of 32 -38
C/90 -100 F, that is a reason to believe that the donor may have altered
or substituted the specimen, and another specimen shall be collected under
direct observation of a person of the same gender and both specimens shall
be forwarded to the laboratory for testing. The agency shall select the
observer if there is no collection site person of the same gender
available. A donor may volunteer to have his or her oral temperature taken
to provide evidence to counter the reason to believe the donor may have
altered or substituted the specimen caused by the specimen's temperature
falling outside the prescribed range.

(14) Immediately after the specimen is collected, the collection site
person shall also inspect the specimen to determine its color and look for
any signs of contaminants. Any unusual findings shall be noted on the
specimen chain of custody form.

(15) All specimens suspected of being adulterated or diluted shall be
forwarded to the laboratory for testing.

(16) When there is any reason to believe that a donor may have altered
or substituted the specimen to be provided, another specimen shall be
obtained as soon as possible under the direct observation of a person of
the same gender and both specimens shall be forwarded to the laboratory
for testing. The agency shall select the observer if there is no
collection site person of the same gender available.

(17) Both the donor and the collection site person shall keep the
specimen bottle/container in view at all times prior to its being sealed
and labeled. If the specimen is transferred from a specimen container to a
specimen bottle, the collection site person shall request the donor to
observe the transfer of the specimen and the placement of the
tamper-evident seal/tape on the bottle. The tamper-evident seal may be in
the form of evidence tape, a self- sealing bottle cap with both a
tamper-evident seal and unique coding, cap and bottle systems that can
only be sealed one time, or any other system that ensures any tampering
with the specimen will be evident to laboratory personnel during the
accessioning process.

(18) The collection site person and the donor shall be present at the
same time during procedures outlined in paragraphs (f)(19)-(f)(22) of this
section.

(19) The collection site person shall place securely on the specimen
bottle an identification label which contains the date, the donor's
specimen number, and any other identifying information provided or
required by the agency.

(20) The donor shall initial the identification label on the specimen
bottle for the purpose of certifying that it is the specimen collected
from him or her.

(21) The collection site person shall enter on the specimen chain of
custody form all information identifying the specimen.

(22) The donor shall be asked to read and sign a statement on the
specimen chain of custody form certifying that the specimen identified as
having been collected from him or her is in fact that specimen he or she
provided.

(23) Based on a reason to believe that the donor may alter or
substitute the specimen to be provided, a higher level supervisor shall
review and concur in advance with any decision by a collection site person
to obtain a specimen under direct observation. The person directly
observing the specimen collection shall be of the same gender. The agency
shall select the observer if there is no collection site person of the
same gender available.

(24) The collection site person shall complete the specimen chain of
custody form.

(25) The urine specimen and specimen chain of custody form are now
ready for shipment. If the specimen is not immediately prepared for
shipment, it shall be appropriately safeguarded during temporary storage.

(26) While any part of the above chain of custody procedures is being
performed, it is essential that the urine specimen and custody documents
be under the control of the involved collection site person. If the
involved collection site person leaves his or her work station
momentarily, the urine specimen and specimen chain of custody form shall
be taken with him or her or shall be secured. After the collection site
person returns to the work station, the custody process will continue. If
the collection site person is leaving for an extended period of time, the
specimen shall be packaged for mailing before he or she leaves the site.

(g) Collection Control. To the maximum extent possible,
collection site personnel shall keep the donor's specimen bottle within
sight both before and after the donor has urinated. After the specimen is
collected, it shall be properly sealed and labeled. A specimen chain of
custody form shall be used for maintaining control and accountability of
each specimen. The date and purpose shall be documented on a specimen
chain of custody form each time a specimen is handled or transferred and
every individual in the chain shall be identified. Every effort shall be
made to minimize the number of persons handling specimens.

(h) Split Specimens. An agency may, but is not required to, use
a split specimen method of collection. If the urine specimen is split into
two specimen bottles (hereinafter referred to as Bottle A and Bottle B)
the following procedure shall be used:

(1) The donor shall urinate into either a specimen bottle or specimen
container. The collection site person, in the presence of the donor, after
determining specimen temperature, pours the urine into two specimen
bottles that are labeled Bottle A and Bottle B or, if Bottle A was used to
collect the specimen, pours an appropriate amount into Bottle B. A minimum
of 45 mL of urine is required when using a split specimen procedure, i.e.,
30 mL for Bottle A and 15 mL for Bottle B.

(2) The Bottle A specimen, containing a minimum of 30 mL of urine, is
to be used for the drug test. If there is no additional urine available
for the second specimen bottle (Bottle B), the first specimen bottle
(Bottle A) shall nevertheless be processed for testing.

(3) A minimum of 15 mL of urine shall be poured into the second
specimen bottle (Bottle B).

(4) All requirements of this part shall be followed with respect to
Bottle A and Bottle B, including the requirements that a copy of the chain
of custody form accompany each bottle processed under split sample
procedures.

(5) The collection site shall send the split specimens (Bottle A and
Bottle B) at the same time to the laboratory that will be testing the
Bottle A specimen.

(6) If the test of the first specimen bottle (Bottle A) is verified
positive by the MRO, the MRO shall report the result to the agency. Only
the donor may request through the MRO that the second specimen bottle
(Bottle B) be tested in an HHS-certified laboratory for presence of the
drug(s) for which a positive result was obtained in the test of the first
specimen bottle (Bottle A). The MRO shall honor such a request if it is
made within 72 hours of the donor's having received notice that he or she
tested positive. The result of this test is transmitted to the MRO without
regard to the cutoff levels used to test the first specimen bottle (Bottle
A).

(7) Any action taken by a Federal agency as a result of an MRO verified
positive drug test (e.g., removal from performing a safety-sensitive
function) may proceed whether Bottle B is or is not tested.

(8) If the result of the test on the second specimen bottle (Bottle B)
fails to reconfirm the result reported for Bottle A, the MRO shall void
the test result for Bottle A and the donor shall re-enter the group
subject to random testing as if the test had not been conducted. The MRO
shall notify the Federal agency when a failed to reconfirm has occurred
and the agency shall contact the Secretary. The Secretary will investigate
the failed to reconfirm result and attempt to determine the reason for the
inconsistent results between Bottle A and Bottle B. HHS will report its
findings to the agency including recommendations and/or actions taken to
prevent the recurrence of the failed to reconfirm result.

(i) Transportation to Laboratory. Collection site personnel
shall arrange to ship the collected specimens to the drug testing
laboratory. The specimens shall be placed in containers designed to
minimize the possibility of damage during shipment, for example, specimen
boxes or padded mailers; and those containers shall be securely sealed to
eliminate the possibility of undetected tampering. The collection site
personnel shall ensure that the specimen chain of custody form is enclosed
within each container sealed for shipment to the drug testing laboratory.
Since specimens are sealed in packages that would indicate any tampering
during transit to the laboratory and couriers, express carriers, and
postal service personnel do not have access to the chain of custody forms,
there is no requirement that such personnel document chain of custody for
the package during transit.

(i) Certification as a laboratory director by the State in forensic or
clinical laboratory toxicology; or

(ii) A Ph.D. in one of the natural sciences with an adequate
undergraduate and graduate education in biology, chemistry, and
pharmacology or toxicology; or

(iii) Training and experience comparable to a Ph.D. in one of the
natural sciences, such as a medical or scientific degree with additional
training and laboratory/research experience in biology, chemistry, and
pharmacology or toxicology; and

(iv) In addition to the requirements in (i),(ii), and (iii) above,
minimum qualifications also require:

(A) Appropriate experience in analytical forensic toxicology including
experience with the analysis of biological material for drugs of abuse,
and

(B) Appropriate training and/or experience in forensic applications of
analytical toxicology, e.g., publications, court testimony, research
concerning analytical toxicology of drugs of abuse, or other factors which
qualify the individual as an expert witness in forensic toxicology.

(3) This individual shall be engaged in and responsible for the
day-to-day management of the drug testing laboratory even where another
individual has overall responsibility for an entire multispecialty
laboratory.

(4) This individual shall be responsible for ensuring that there are
enough personnel with adequate training and experience to supervise and
conduct the work of the drug testing laboratory. He or she shall assure
the continued competency of laboratory personnel by documenting their
inservice training, reviewing their work performance, and verifying their
skills.

(5) This individual shall be responsible for the laboratory`s having a
procedure manual which is complete, up-to-date, available for personnel
performing tests, and followed by those personnel. The procedure manual
shall be reviewed, signed, and dated by this responsible person whenever
procedures are first placed into use or changed or when a new individual
assumes responsibility for management of the drug testing laboratory.
Copies of all procedures and dates on which they are in effect shall be
maintained. (Specific contents of the procedure manual are described in
section 2.4(n)(1))

(6) This individual shall be responsible for maintaining a quality
assurance program to assure the proper performance and reporting of all
test results; for maintaining acceptable analytical performance for all
controls and standards; for maintaining quality control testing; and for
assuring and documenting the validity, reliability, accuracy, precision,
and performance characteristics of each test and test system.

(7) This individual shall be responsible for taking all remedial
actions necessary to maintain satisfactory operation and performance of
the laboratory in response to quality control systems not being within
performance specifications, errors in result reporting or in analysis of
performance testing results. This individual shall ensure that sample
results are not reported until all corrective actions have been taken and
he or she can assure that the results provided are accurate and reliable.

(b) Certifying Test Results. The laboratory's urine drug testing
facility shall have a certifying scientist(s), as defined in section 1.2,
who reviews all pertinent data and quality control results in order to
attest to the validity of the laboratory's test reports. A laboratory may
designate certifying scientists that are qualified to certify only results
that are negative on the initial test and certifying scientists that are
qualified to certify both initial and confirmatory tests.

(c) Day-to-Day Operations and Supervision of Analysts. The
laboratory's urine drug testing facility shall have an individual(s) to be
responsible for day-to-day operations and to supervise the technical
analysts. This individual(s) shall have at least a bachelor's degree in
the chemical or biological sciences or medical technology or equivalent.
He or she shall have training and experience in the theory and practice of
the procedures used in the laboratory, resulting in his or her thorough
understanding of quality control practices and procedures; the review,
interpretation, and reporting of test results; maintenance of chain of
custody; and proper remedial actions to be taken in response to test
systems being out of control limits or detecting aberrant test or quality
control results.

(d) Other Personnel. Other technicians or nontechnical staff
shall have the necessary training and skills for the tasks assigned.

(e) Training. The laboratory's urine drug testing program shall
make available continuing education programs to meet the needs of
laboratory personnel.

(f) Files. Laboratory personnel files shall include: resume of
training and experience; certification or license, if any; references; job
descriptions; records of performance evaluation and advancement; incident
reports; and results of tests which establish employee competency for the
position he or she holds, such as a test for color blindness, if
appropriate.

Section 2.4 Laboratory Analysis Procedures.

(a) Security and Chain of Custody. (1) Drug testing laboratories
shall be secure at all times. They shall have in place sufficient security
measures to control access to the premises and to ensure that no
unauthorized personnel handle specimens or gain access to the laboratory
processes or to areas where records are stored. Access to these secured
areas shall be limited to specifically authorized individuals whose
authorization is documented. With the exception of personnel authorized to
conduct inspections on behalf of Federal agencies for which the laboratory
is engaged in urine testing or on behalf of the Secretary or emergency
personnel (e.g., firefighters and medical rescue teams), all authorized
visitors and maintenance and service personnel shall be escorted at all
times. The laboratory shall maintain a record that documents the dates,
time of entry and exit, and purpose of entry of authorized visitors,
maintenance, and service personnel accessing secured areas.

(2) Laboratories shall use chain of custody procedures to maintain
control and accountability of specimens from receipt through completion of
testing, reporting of results, during storage, and continuing until final
disposition of specimens. The date and purpose shall be documented on an
appropriate chain of custody form each time a specimen is handled or
transferred, and every individual in the chain shall be identified.
Accordingly, authorized technicians shall be responsible for each urine
specimen or aliquot in their possession and shall sign and complete chain
of custody forms for those specimens or aliquots as they are received.

(b) Receiving. (1) When a shipment of specimens is received,
laboratory personnel shall inspect each package for evidence of possible
tampering and compare information on specimen bottles within each package
to the information on the accompanying chain of custody forms. Any direct
evidence of tampering or discrepancies in the information on specimen
bottles and the specimen chain of custody forms attached to the shipment
shall be immediately reported to the agency and shall be noted on the
specimen chain of custody forms which shall accompany the specimens while
they are in the laboratory's possession.

(2) Specimen bottles will normally be retained within the laboratory's
accession area until all analyses have been completed. Aliquots and
laboratory chain of custody forms shall be used by laboratory personnel
for conducting initial and confirmatory tests while the original specimen
and specimen chain of custody form remain in secure storage.

(c) Short-Term Refrigerated Storage. Specimens that do not
receive an initial test within 7 days of arrival at the laboratory shall
be placed in secure refrigeration units. Temperatures shall not exceed 6
C. Emergency power equipment shall be available in case of prolonged power
failure.

(d) Specimen Processing. Laboratory facilities for urine drug
testing will normally process specimens by grouping them into batches. The
number of specimens in each batch may vary significantly depending on the
size of the laboratory and its workload. When conducting either initial or
confirmatory tests, every batch shall satisfy the quality control
requirements in sections 2.5 (b) and (c), respectively.

(e) Initial Test. (1) The initial test shall use an immunoassay
which meets the requirements of the Food and Drug Administration for
commercial distribution. The following initial cutoff levels shall be used
when screening specimens to determine whether they are negative for these
five drugs or classes of drugs:

(2) These test levels are subject to change by the Department of Health
and Human Services as advances in technology or other considerations
warrant identification of these substances at other concentrations. The
agency requesting the authorization to include other drugs shall submit to
the Secretary in writing the agency's proposed initial test methods,
testing levels, and proposed performance test program.

(3) Specimens that test negative on all initial immunoassay tests will
be reported negative. No further testing of these negative specimens for
drugs is permitted and the specimens shall either be discarded or pooled
for use in the laboratory's internal quality control program.

(4) Multiple initial tests (also known as rescreening) for the same
drug or drug class may be performed provided that all tests meet all
Guideline cutoffs and quality control requirements (see section 2.5(b)).
Examples: a test is performed by immunoassay technique "A" for
all drugs using the HHS cutoff levels, but presumptive positive
amphetamines are forwarded for immunoassay technique "B" to
eliminate any possible presumptive positives due to structural analogues;
a valid analytical result cannot be obtained using immunoassay technique
"A" and immunoassay technique "B" is used in an
attempt to obtain a valid analytical result.

(f) Confirmatory Test. (1) All specimens identified as positive
on the initial test shall be confirmed for the class(es) of drugs screened
positive on the initial test using gas chromatography/mass spectrometry
(GC/MS) at the cutoff values listed in this paragraph. All confirmations
shall be by quantitative analysis. Concentrations which exceed the linear
region of the standard curve shall be documented in the laboratory record
as "exceeds the linear range of the test."

(2) These test levels are subject to change by the Department of Health
and Human Services as advances in technology or other considerations
warrant identification of these substances at other concentrations. The
agency requesting the authorization to include other drugs shall submit to
the Secretary in writing the agency's proposed confirmatory test methods,
testing levels, and proposed performance test program.

(3) Specimens that test negative on confirmatory tests shall be
reported negative. No further testing of these specimens for drugs is
permitted and the specimens shall either be discarded or pooled for use in
the laboratory's internal quality control program.

(g) Reporting Results. (1) The laboratory shall report test
results to the agency's MRO within an average of 5 working days after
receipt of the specimen by the laboratory. Before any test result is
reported (the results of initial tests, confirmatory tests, or quality
control data), it shall be reviewed and the test certified as an accurate
report by a certifying scientist who satisfies the requirements described
by the definition in section 1.2. The report shall identify the
drugs/metabolites tested for, whether positive or negative, and the cutoff
for each, the specimen number assigned by the agency, and the drug testing
laboratory specimen identification number.

(2) Except as otherwise provided by this subsection, the laboratory
shall report as negative all specimens which are negative on the initial
test or negative on the confirmatory test. Only specimens confirmed
positive shall be reported positive for a specific drug. For amphetamines,
to report a specimen positive for methamphetamine only, the specimen must
also contain amphetamine at a concentration equal to or greater than 200
ng/mL by the confirmatory test. If this criterion is not met, the specimen
must be reported as negative for methamphetamine.

(3) The MRO may request from the laboratory and the laboratory shall
provide quantitation of test results. The MRO may not disclose
quantitation of test results to the agency but shall report only whether
the test was positive or negative.

(4) The laboratory may transmit results to the MRO by various
electronic means (for example, teleprinters, facsimile, or computer) in a
manner designed to ensure confidentiality of the information. Results may
not be provided verbally by telephone. The laboratory must ensure the
security of the data transmission and limit access to any data
transmission, storage, and retrieval system.

(5) The laboratory shall send only to the MRO a certified copy of the
original chain of custody form signed by a certifying scientist.

(6) The laboratory shall provide to the agency official responsible for
coordination of the Drug-Free Workplace program a monthly statistical
summary of urinalysis testing of Federal employees and shall not include
in the summary any personal identifying information. Initial and
confirmation data shall be included from test results reported within that
month. Normally this summary shall be forwarded by registered or certified
mail not more than 14 calendar days after the end of the month covered by
the summary. The summary shall contain the following information:

(7) The laboratory shall make available copies of all analytical
results for Federal drug testing programs when requested by HHS or any
Federal agency for which the laboratory is performing drug testing
services.

(8) Unless otherwise instructed by the agency in writing, all records
pertaining to a given urine specimen shall be retained by the drug testing
laboratory for a minimum of 2 years.

(h) Long-Term Storage. Long-term frozen storage (-20 C or less)
ensures that positive urine specimens will be available for any necessary
retest. Unless otherwise authorized in writing by the agency, drug testing
laboratories shall retain and place in properly secured long- term frozen
storage for a minimum of 1 year all specimens confirmed positive. Within
this 1- year period an agency may request the laboratory to retain the
specimen for an additional period of time. If no such request is received,
the laboratory may discard the specimen after the end of 1 year, except
that the laboratory shall be required to maintain any specimens under
legal challenge for an indefinite period.

(i) Retesting of a Specimen (i.e., the reanalysis by gas
chromatography/mass spectrometry of a specimen previously reported
positive or the testing of Bottle B of a split specimen collection).
Because some analytes deteriorate or are lost during freezing and/or
storage, quantitation for a retest is not subject to a specific cutoff
requirement but must provide data sufficient to confirm the presence of
the drug or metabolite.

(j) Subcontracting. Drug testing laboratories shall not
subcontract and shall perform all work with their own personnel and
equipment unless otherwise authorized by the agency. The laboratory must
be capable of performing testing for the five classes of drugs (marijuana,
cocaine, opiates, phencyclidine, and amphetamines) using the initial
immunoassay and confirmatory GC/MS methods specified in these Guidelines.

(2) Laboratories certified in accordance with Subpart C of these
Guidelines shall have the capability, at the same laboratory premises, of
performing initial and confirmatory tests for each drug or metabolite for
which service is offered.

(l) Inspections. The Secretary, any Federal agency utilizing the
laboratory, or any organization performing laboratory certification on
behalf of the Secretary may reserve the right to inspect the laboratory at
any time. Agency contracts with laboratories for drug testing, as well as
contracts for collection site services, shall permit the agency to conduct
unannounced inspections. In addition, prior to the award of a contract the
agency may carry out preaward inspections and evaluation of the procedural
aspects of the laboratory's drug testing operation.

(m) Documentation. The drug testing laboratories shall maintain
and make available for at least 2 years documentation of all aspects of
the testing process. This 2-year period may be extended upon written
notification by HHS or by any Federal agency for which laboratory services
are being provided. The required documentation shall include personnel
files on all individuals authorized to have access to specimens; chain of
custody forms; quality assurance/quality control records; procedure
manuals; all test data (including calibration curves and any calculations
used in determining test results); reports; performance records on
performance testing; performance on certification inspections; and hard
copies of computer- generated data. The laboratory shall be required to
maintain documents for any specimen under legal challenge for an
indefinite period.

(n) Additional Requirements for Certified Laboratories.

(1) Procedure Manual. Each laboratory shall have a procedure
manual which includes the principles of each test, preparation of
reagents, standards and controls, calibration procedures, derivation of
results, linearity of methods, sensitivity of the methods, cutoff values,
mechanisms for reporting results, controls, criteria for unacceptable
specimens and results, remedial actions to be taken when the test systems
are outside of acceptable limits, reagents and expiration dates, and
references. Copies of all procedures and dates on which they are in effect
shall be maintained as part of the manual.

(2) Calibrators and Controls. Laboratory calibrators and
controls shall be prepared using pure drug reference materials, stock
standard solutions obtained from other laboratories, or standard solutions
obtained from commercial manufacturers. The calibrators and controls shall
be properly labeled as to content and concentration. The standards (e.g.,
pure reference materials, stock standard solutions, purchased standards)
shall be labeled with the following dates: when received (if applicable);
when prepared or opened; when placed in service; and expiration date.

(3) Instruments and Equipment. (i) Volumetric pipettes and
measuring devices shall be certified for accuracy or be checked by
gravimetric, colorimetric, or other verification procedure. Automatic
pipettes and dilutors shall be checked for accuracy and reproducibility
before being placed in service and checked periodically thereafter.

(ii) There shall be written procedures for instrument set-up and normal
operation, a schedule for checking critical operating characteristics for
all instruments, tolerance limits for acceptable function checks, and
instructions for major troubleshooting and repair. Records shall be
available on preventive maintenance.

(4) Remedial Actions. There shall be written procedures for the
actions to be taken when systems are out of acceptable limits or errors
are detected. There shall be documentation that these procedures are
followed and that all necessary corrective actions are taken. There shall
also be in place systems to verify all stages of testing and reporting and
documentation that these procedures are followed.

(5) Personnel Available to Testify at Proceedings. A laboratory
shall have qualified personnel available to testify in an administrative
or disciplinary proceeding against a Federal employee when that proceeding
is based on positive urinalysis results reported by the laboratory.

(6) Restrictions. The laboratory shall not enter into any
relationship with an agency's MRO that may be construed as a potential
conflict of interest or derive any financial benefit by having an agency
use a specific MRO.

Section 2.5 Quality Assurance and Quality Control.

(a) General. Drug testing laboratories shall have a quality
assurance program which encompasses all aspects of the testing process
including but not limited to specimen acquisition, chain of custody,
security and reporting of results, initial and confirmatory testing,
certification of calibrators and controls, and validation of analytical
procedures. Quality assurance procedures shall be designed, implemented,
and reviewed to monitor the conduct of each step of the testing process.

(b) Laboratory Quality Control Requirements for Initial Tests.
Each analytical run of specimens to be screened shall include:

(3) At least one positive control with the drug or metabolite at or
near the threshold (cutoff);

(4) A sufficient number of calibrators to ensure and document the
linearity of the assay method over time in the concentration area of the
cutoff. After acceptable values are obtained for the known calibrators,
those values will be used to calculate sample data;

(5) A minimum of 10 percent of the total specimens and quality control
samples in each analytical run shall be quality control samples; and

(6) One percent of each run, with a minimum of at least one sample,
shall be the laboratory's blind quality control samples to appear as
normal samples to the laboratory analysts. Implementation of procedures to
ensure that carryover does not contaminate the testing of an donor's
specimen shall be documented.

(c) Laboratory Quality Control Requirements for Confirmation Tests.
Each analytical run of specimens to be confirmed shall include:

(2) Positive calibrator(s) and control(s) fortified with drug or
metabolite; and

(3) At least one positive control with the drug or metabolite at or
near the threshold (cutoff). The linearity and precision of the method
shall be periodically documented. Implementation of procedures to ensure
that carryover does not contaminate the testing of a donor's specimen
shall also be documented.

(d) Agency Blind Sample Program.

(1) Agencies shall only purchase blind quality control materials that:
(a) have been certified by immunoassay and GC/MS and (b) have stability
data which verifies those materials' performance over time.

(2) During the initial 90-day period of any new drug testing program,
each agency shall submit blind performance test samples to each laboratory
it contracts with in the amount of at least 20 percent of the total number
of specimens submitted (up to a maximum of 200 blind samples) and
thereafter a minimum of 3 percent blind samples (up to a maximum of 100
blind samples) submitted per quarter.

(3) Approximately 80 percent of the blind quality control samples shall
be negative (i.e., certified to contain no drug) and the remaining samples
shall be positive for one or more drugs per sample in a distribution such
that all the drugs to be tested are included in approximately equal
frequencies of challenge. The positive samples shall be spiked only with
those drugs for which the agency is testing.

(4) The agency shall investigate any unsatisfactory blind performance
test sample results and submit its findings to the Secretary. The
Secretary shall continue the investigation to ensure that the laboratory
has corrected the cause of the unsatisfactory performance test result. A
report of the Secretary's investigative findings and the corrective action
taken by the laboratory shall be sent to the agency contracting officer.
The Secretary shall ensure notification of the finding to all other
Federal agencies for which the laboratory is engaged in urine drug testing
and coordinate any necessary action.

(5) Should a false positive error occur on a blind performance test
sample and the error is determined to be an administrative error
(clerical, sample mixup, etc.), the Secretary shall require the laboratory
to take corrective action to minimize the occurrence of the particular
error in the future; and, if there is reason to believe the error could
have been systematic, the Secretary may also require review and reanalysis
of previously run specimens.

(6) Should a false positive error occur on a blind performance test
sample and the error is determined to be a technical or methodological
error, the laboratory shall submit all quality control data from the batch
of specimens which included the false positive specimen. In addition, the
laboratory shall retest all specimens analyzed positive for that drug or
metabolite from the time of final resolution of the error back to the time
of the last satisfactory performance test cycle. This retesting shall be
documented by a statement signed by the Responsible Person. The Secretary
may require an on-site review of the laboratory which may be conducted
unannounced during any hours of operation of the laboratory. The Secretary
has the option of revoking (section 3.13) or suspending (section 3.14) the
laboratory's certification or recommending that no further action be taken
if the case is one of less serious error in which corrective action has
already been taken, thus reasonably assuring that the error will not occur
again.

Section 2.6 Reporting and Review of Results.

(a) Medical Review Officer Shall Review Results. An essential
part of the drug testing program is the final review of results. A
positive test result does not automatically identify an employee/applicant
as an illegal drug user. An individual with a detailed knowledge of
possible alternate medical explanations is essential to the review of
results. This review shall be performed by the MRO prior to the
transmission of results to agency administrative officials.

(b) Medical Review Officer - Qualifications and Responsibilities.
The MRO shall be a licensed physician with knowledge of substance abuse
disorders. The MRO may be an employee of the agency or a contractor for
the agency; however, the MRO shall not be an employee or agent of or have
any financial interest in the laboratory for which the MRO is reviewing
drug testing results. Additionally, the MRO shall not derive any financial
benefit by having an agency use a specific drug testing laboratory or have
any agreement with the laboratory that may be construed as a potential
conflict of interest. The role of the MRO is to review and interpret
positive test results obtained through the agency's testing program. In
carrying out this responsibility, the MRO shall examine alternate medical
explanations for any positive test result. This action could include
conducting a medical interview with the donor, review of the donor's
medical history, or review of any other relevant biomedical factors. The
MRO shall review all medical records made available by the donor when a
confirmed positive test could have resulted from legally prescribed
medication. The MRO shall not, however, consider the results of urine
specimens that are not obtained or processed in accordance with these
Guidelines.

(c) Positive Test Result. Prior to making a final decision to
verify a positive test result, the MRO shall give the donor an opportunity
to discuss the test result with him or her. Following verification of a
positive test result, the MRO shall report the result to the agency's
official designated to receive results.

(d) Verification for Opiates; Review for Prescription Medication.
Before the MRO verifies a confirmed positive result for opiates, he or she
shall determine that there is clinical evidence--in addition to the urine
test--of illegal use of any opium, opiate, or opium derivative (e.g.,
morphine/codeine) listed in Schedule I or II of the Controlled Substances
Act. This requirement does not apply if the confirmatory procedure for
opiates confirms the presence of 6- monoacetylmorphine since the presence
of this metabolite is proof of heroin use.

(e) Reanalysis Authorized. Should any question arise as to the
accuracy or validity of a positive test result, only the MRO is authorized
to order a retest of a single specimen or the Bottle A specimen from a
split specimen collection. Such retests are authorized only at
laboratories certified under these Guidelines.

(f) Result Consistent with Legal Drug Use. If the MRO determines
there is a legitimate medical explanation for the positive test result, he
or she shall take no further action and report the test result as
negative.

(g) Result Scientifically Insufficient. Additionally, the MRO,
based on review of inspection reports, quality control data, and other
pertinent results, may determine that the result is scientifically
insufficient for further action and declare the test specimen negative. In
this situation the MRO may request a retest of the original specimen
before making this decision. (The MRO may request that the retest be
performed by the same laboratory or, as provided in section 2.6(e), that
an aliquot of the original specimen be sent for a retest to an alternate
laboratory which is certified in accordance with these Guidelines.) The
laboratory shall assist in this review process as requested by the MRO by
making available the individual responsible for day-to-day management of
the urine drug testing laboratory or other employee who is a forensic
toxicologist or who has equivalent forensic experience in urine drug
testing, to provide specific consultation as required by the agency. The
MRO shall report to the Secretary all negative findings based on
scientific insufficiency but shall not include any personal identifying
information in such reports.

(h) Reporting Final Results. The MRO shall report the final
results of the drug tests in writing and in a manner designed to ensure
confidentiality of the information.

Section 2.7 Protection of Employee Records.

Consistent with 5 U.S.C. 522a(m) and 48 CFR 24.101-24.104, all
laboratory contracts shall require that the contractor comply with the
Privacy Act, 5 U.S.C. 522a. In addition, laboratory contracts shall
require compliance with patient access and confidentiality provisions of
section 503 of Pub. L. 100-71. The agency shall establish a Privacy Act
System of Records or modify an existing system, or use any applicable
Government-wide system of records to cover both the agency's and the
laboratory's records of employee urinalysis results. The contract and the
Privacy Act System of Records shall specifically require that employee
records be maintained and used with the highest regard for employee
privacy.

In accordance with section 503 of Pub. L. 100-71, any Federal employee
who is the subject of a drug test shall, upon written request, have access
to any records relating to his or her drug test and any records relating
to the results of any relevant certification, review, or
revocation-of-certification proceedings.

Section 3.1 Introduction.

Urine drug testing is a critical component of efforts to combat drug
abuse in our society. Many laboratories are familiar with good laboratory
practices but may be unfamiliar with the special procedures required when
drug test results are used in the employment context. Accordingly, the
following are minimum standards to certify laboratories engaged in urine
drug testing for Federal agencies. Certification, even at the highest
level, does not guarantee accuracy of each result reported by a laboratory
conducting urine drug testing for Federal agencies. Therefore, results
from laboratories certified under these Guidelines must be interpreted
with a complete understanding of the total collection, analysis, and
reporting process before a final conclusion is made.

Section 3.2 Goals and Objectives of Certification.

(a) Uses of Urine Drug Testing. Urine drug testing is an
important tool to identify drug users in a variety of settings. In the
proper context, urine drug testing can be used to deter drug abuse in
general. To be a useful tool, the testing procedure must be capable of
detecting drugs or their metabolites at concentrations indicated in
sections 2.4(e) and 2.4(f).

(b) Need to Set Standards; Inspections. Reliable discrimination
between the presence, or absence, of specific drugs or their metabolites
is critical, not only to achieve the goals of the testing program but to
protect the rights of the Federal employees being tested. Thus, standards
have been set which laboratories engaged in Federal employee urine drug
testing must meet in order to achieve maximum accuracy of test results.
These laboratories will be evaluated by the Secretary or the Secretary's
designee as defined in section 1.2 in accordance with these Guidelines.
The qualifying evaluation will involve three rounds of performance testing
plus an on-site inspection. Maintenance of certification requires
participation in a quarterly performance testing program plus periodic,
on-site inspections. One inspection following successful completion of a
performance testing regimen is required for initial certification. This
must be followed by a second inspection within 3 months, after which
biannual inspections will be required to maintain certification.

(c) Urine Drug Testing Applies Analytical Forensic Toxicology.
The possible impact of a positive test result on an individual's
livelihood or rights, together with the possibility of a legal challenge
of the result, sets this type of test apart from most clinical laboratory
testing. In fact, urine drug testing should be considered a special
application of analytical forensic toxicology. That is, in addition to the
application of appropriate analytical methodology, the specimen must be
treated as evidence, and all aspects of the testing procedure must be
documented and available for possible court testimony. Laboratories
engaged in urine drug testing for Federal agencies will require the
services and advice of a qualified forensic toxicologist, or individual
with equivalent qualifications (both training and experience) to address
the specific needs of the Federal drug testing program, including the
demands of chain of custody of specimens, security, proper documentation
of all records, storage of positive specimens for later or independent
testing, presentation of evidence in court, and expert witness testimony.

Section 3.3 General Certification Requirements.

A laboratory must meet all the pertinent provisions of these Guidelines
in order to qualify for and maintain certification under these standards.

Section 3.4 Capability to Test for Five Classes of Drugs.

To be certified, a laboratory must be capable of testing for at least
the following five classes of drugs: marijuana, cocaine, opiates,
amphetamines, and phencyclidine using the initial immunoassay and
quantitative confirmatory GC/MS methods specified in these Guidelines. The
certification program will be limited to the five classes of drugs
(sections 2.1(a)(1) and (2)) and the methods (sections 2.4(e) and (f))
specified in these Guidelines. The laboratory will be surveyed and
performance tested only for these methods and drugs. Certification of a
laboratory indicates that any test result reported by the laboratory for
the Federal Government meets the standards in these Guidelines for the
five classes of drugs using the methods specified. Certified laboratories
must clearly inform all unregulated, private clients when their specimens
are being tested using procedures that are different from those for which
the laboratory is certified (i.e., testing specimens not under the
Guidelines).

Section 3.5 Initial and Confirmatory Capability at Same Site.

Certified laboratories shall have the capability, at the same
laboratory site, of performing both initial immunoassays and confirmatory
GC/MS tests (sections 2.4(e) and (f)) for marijuana, cocaine, opiates,
amphetamines, and phencyclidine and for any other drug or metabolite for
which agency drug testing is authorized (sections 2.1(a)(1) and (2)). All
positive initial test results shall be confirmed prior to reporting them.

Section 3.6 Personnel.

Laboratory personnel shall meet the requirements specified in section
2.3 of these Guidelines. These Guidelines establish the exclusive
standards for qualifying or certifying those laboratory personnel involved
in urinalysis testing whose functions are prescribed by these Guidelines.
A certification of a laboratory under these Guidelines shall be a
determination that these qualification requirements have been met.

Section 3.7 Quality Assurance and Quality Control.

Drug testing laboratories shall have a quality assurance program which
encompasses all aspects of the testing process, including but not limited
to specimen acquisition, chain of custody, security and reporting of
results, initial and confirmatory testing, and validation of analytical
procedures. Quality control procedures shall be designed, implemented, and
reviewed to monitor the conduct of each step of the process of testing for
drugs as specified in section 2.5 of these Guidelines.

Section 3.8 Security and Chain of Custody.

Section 3.9 One-Year Storage for Confirmed Positives.

All confirmed positive specimens shall be retained in accordance with
the provisions of section 2.4(h) of these Guidelines.

Section 3.10 Documentation.

The laboratory shall maintain and make available for at least 2 years
documentation in accordance with the specifications in section 2.4(m).

Section 3.11 Reports.

The laboratory shall report test results in accordance with the
specifications in section 2.4(g).

Section 3.12 Certification.

(a) General. The Secretary may certify any laboratory that meets
the standards in these Guidelines to conduct urine drug testing. In
addition, the Secretary may consider to be certified any laboratory that
is certified by an HHS-recognized certification program in accordance with
these Guidelines.

(b) Criteria. In determining whether to certify a laboratory or
to accept the certification of an HHS-recognized certification program in
accordance with these Guidelines, the Secretary shall consider the
following criteria:

(1) The adequacy of the laboratory facilities;
(2) The expertise and experience of the laboratory personnel;
(3) The excellence of the laboratory's quality assurance/ quality control
program;
(4) The performance of the laboratory on any performance tests;
(5) The laboratory's compliance with standards as reflected in any
laboratory inspections; and
(6) Any other factors affecting the reliability and accuracy of drug tests
and reporting
done by the laboratory.

(c) Corrective Action by Certified Laboratories. A laboratory
must meet all the pertinent provisions of these Guidelines in order to
qualify for and maintain certification. The Secretary has broad discretion
to take appropriate action to ensure the full reliability and accuracy of
drug testing and reporting, to resolve problems related to drug testing,
and to enforce all standards set forth in these Guidelines. The Secretary
shall have the authority to issue directives to any laboratory suspending
the use of certain analytical procedures when necessary to protect the
integrity of the testing process; ordering any laboratory to undertake
corrective actions to respond to material deficiencies identified by an
inspection or through proficiency testing; ordering any laboratory to send
aliquots of urine specimens to another laboratory for retesting when
necessary to ensure the accuracy of testing under these Guidelines;
ordering the review of results for specimens tested under the Guidelines
for private sector clients to the extent necessary to ensure the full
reliability of drug testing for Federal agencies; and ordering any other
action necessary to address deficiencies in drug testing, analysis,
specimen collection, chain of custody, reporting of results, or any other
aspect of the certification program.

Section 3.13 Revocation.

(a) General. The Secretary shall revoke certification of any
laboratory certified under these provisions or accept revocation by an
HHS-recognized certification program in accordance with these Guidelines
if the Secretary determines that revocation is necessary to ensure the
full reliability and accuracy of drug tests and the accurate reporting of
test results.

(b) Factors to Consider. The Secretary shall consider the
following factors in determining whether revocation is necessary:

(1) Unsatisfactory performance in analyzing and reporting the results
of drug tests; for example, a false positive error in reporting the
results of an employee's drug test;

(3) A material violation of a certification standard or a contract term
or other condition imposed on the laboratory by a Federal agency using the
laboratory's services;

(4) Conviction for any criminal offense committed as an incident to
operation of the laboratory; or

(5) Any other cause which materially affects the ability of the
laboratory to ensure the full reliability and accuracy of drug tests and
the accurate reporting of results.

(c) Period and Terms. The period and terms of revocation shall
be determined by the Secretary and shall depend upon the facts and
circumstances of the revocation and the need to ensure accurate and
reliable drug testing of Federal employees.

Section 3.14 Suspension.

(a) Criteria. Whenever the Secretary has reason to believe that
revocation may be required and that immediate action is necessary in order
to protect the interests of the United States and its employees, the
Secretary may immediately suspend a laboratory's certification to conduct
urine drug testing for Federal agencies. The Secretary may also accept
suspension of certification by an HHS-recognized certification program in
accordance with these Guidelines.

(b) Period and Terms. The period and terms of suspension shall
be determined by the Secretary and shall depend upon the facts and
circumstances of the suspension and the need to ensure accurate and
reliable drug testing of Federal employees.

Section 3.15 Notice.

(a) Written Notice. When a laboratory is suspended or the
Secretary seeks to revoke certification, the Secretary shall immediately
serve the laboratory with written notice of the suspension or proposed
revocation by facsimile mail, personal service, or registered or certified
mail, return receipt requested. This notice shall state the following:

(1) The reasons for the suspension or proposed revocation;
(2) The terms of the suspension or proposed revocation; and
(3) The period of suspension or proposed revocation.

(b) Opportunity for Informal Review. The written notice shall
state that the laboratory will be afforded an opportunity for an informal
review of the suspension or proposed revocation if it so requests in
writing within 30 days of the date the laboratory received the notice, or
if expedited review is requested, within 3 days of the date the laboratory
received the notice. Subpart D contains detailed procedures to be followed
for an informal review of the suspension or proposed revocation.

(c) Effective Date. A suspension shall be effective immediately.
A proposed revocation shall be effective 30 days after written notice is
given or, if review is requested, upon the reviewing official's decision
to uphold the proposed revocation. If the reviewing official decides not
to uphold the suspension or proposed revocation, the suspension shall
terminate immediately and any proposed revocation shall not take effect.

(d) HHS-Recognized Certification Program. The Secretary's
responsibility under this section may be carried out by an HHS-recognized
certification program in accordance with these Guidelines.

(e) Public Notice. The Secretary will publish in the Federal
Register the name, address, and telephone number of any laboratory that
has its certification suspended or revoked under section 3.13 or section
3.14, respectively, and the name of any laboratory which has its
suspension lifted. The Secretary shall provide to any member of the public
upon request the written notice provided to a laboratory that has its
certification suspended or revoked, as well as the reviewing official's
written decision which upholds or denies the suspension or proposed
revocation under the procedures of subpart D.

Section 3.16 Recertification.

Following revocation, a laboratory may apply for recertification.
Unless otherwise provided by the Secretary in the notice of revocation
under section 3.13(a) or the reviewing official's decision under section
4.9(e) or 4.14(a), a laboratory which has had its certification revoked
may apply for certification in accordance with this section. In order to
be certified, the laboratory shall meet the criteria of section 3.12(b),
as well as all other requirements of these Guidelines, including the
successful participation in three cycles of performance testing (sections
3.17(b) and 3.19(a)) and a laboratory inspection (sections 3.2(b) and
3.20). Once certified, the laboratory must undergo a second inspection
within three months, after which biannual inspections will be required to
maintain certification (section 3.2(b)), as well as participation in the
quarterly performance testing program (sections 3.1(b) and 3.17(c)).

Section 3.17 Performance Testing (PT) Requirement for Certification.

(a) An Initial and Continuing Requirement. The PT program is a
part of the initial evaluation of a laboratory seeking certification (both
PT and laboratory inspection are required) and of the continuing
assessment of laboratory performance necessary to maintain this
certification.

(b) Three Initial Cycles Required. Successful participation in
three cycles of testing shall be required before a laboratory is eligible
to be considered for certification.

(c) Four Challenges Per Year. After certification, laboratories
shall be challenged with at least 10 PT samples on a quarterly cycle.

(d) Laboratory Procedures Identical for Performance Test and Routine
Employee Specimens. All procedures associated with the handling and
testing of the PT samples by the laboratory shall to the greatest extent
possible be carried out in a manner identical to that applied to routine
laboratory specimens, unless otherwise specified.

(e) Blind Performance Test. Any certified laboratory shall be
subject to blind PT samples (see section 2.5(d)). Performance on blind PT
samples shall be at the same level as for the open or non-blind PT
samples.

(f) Reporting - Open Performance Test. The laboratory shall
report results of open PT samples to the certifying organization in the
same manner as specified in section 2.4(g)(2) for routine specimens.

Section 3.18 Performance Test Samples Composition.

(a) Description of the Drugs. PT samples shall contain those
drugs and metabolites which each certified laboratory must be prepared to
assay in concentration ranges that allow detection of the analytes by
commonly used immunoassay screening techniques. These levels are generally
in the range of concentrations which might be expected in the urine of
recent drug users. For some drug analytes, the sample composition will
consist of the parent drug as well as major metabolites. In some cases,
more than one drug class may be included in one sample, but generally no
more than two drugs will be present in any one sample in order to imitate
the type of specimen which a laboratory normally encounters. For any
particular PT cycle, the actual composition of kits going to different
laboratories will vary but, within any annual period, all laboratories
participating will have analyzed the same total set of samples.

(b) Concentrations. PT samples (as differentiated from blind
quality control samples) shall be spiked with the drug classes and their
metabolites that are required for certification (marijuana, cocaine,
opiates, amphetamines, and phencyclidine) with concentration levels set
by, but not limited to, one of the following schema: (1) at least 20
percent above the cutoff limit for either the initial assay or the
confirmatory test, depending on which is to be evaluated; (2) below the
cutoff limit as retest samples (for GC/MS quantitation); and, (3) below
the cutoff limit for special purposes. Some PT samples may be identified
for GC/MS assay only (retest samples). Blanks shall contain less than 2
ng/mL of any of the target drugs. These concentration and drug types may
be changed periodically in response to factors such as changes in
detection technology and patterns of drug use. Finally, PT samples may be
constituted with interfering substances.

Section 3.19 Evaluation of Performance Testing.

(a) Initial Certification. (1) An applicant laboratory shall not
report any false positive result during PT for initial certification. Any
false positive will automatically disqualify a laboratory from further
consideration.

(2) An applicant laboratory shall maintain an overall grade level of 90
percent for the three cycles of PT required for initial certification,
i.e., it must correctly identify and confirm 90 percent of the total drug
challenges. Any laboratory which achieves a score on any one cycle of the
initial certification such that it can no longer achieve a total grade of
90 percent over the three consecutive PT cycles will be immediately
disqualified from further consideration.

(3) An applicant laboratory shall obtain quantitative values for at
least 80 percent of the total drug challenges which are ±20 percent or ±2
standard deviations (whichever range is larger) of the calculated
reference group mean. Failure to achieve 80 percent will result in
disqualification.

(4) An applicant laboratory shall not obtain any quantitative values
that differ by more than 50 percent from the calculated reference group
mean. Any quantitative values that differ by more than 50 percent will
result in disqualification.

(5) For any individual drug, an applicant laboratory shall successfully
detect and quantitate in accordance with paragraphs (a)(2),(a)(3), and
(a)(4) of this section at least 50 percent of the total drug challenges.
Failure to successfully quantitate at least 50 percent of the challenges
for any individual drug will result in disqualification.

(b.) Ongoing Testing of Certified Laboratories. (1) False
Positives and Procedures for Dealing with Them. No false drug
identifications are acceptable for any drugs for which a laboratory offers
service. Under some circumstances a false positive test may result in
suspension or revocation of certification. The most serious false
positives are by drug class, such as reporting THC in a blank specimen or
reporting cocaine in a specimen known to contain only opiates.
Misidentifications within a class (e.g., codeine for morphine) are also
false positives which are unacceptable in an appropriately controlled
laboratory, but they are clearly less serious errors than
misidentification of a class. The following procedures shall be followed
when dealing with a false positive:

(i) The agency detecting a false positive error shall immediately
notify the laboratory and the Secretary of any such error.

(ii) The laboratory shall provide the Secretary with a written
explanation of the reasons for the error within 5 working days. If
required by paragraph (b)(1)(v) below, this explanation shall include the
submission of all quality control data from the batch of specimens that
included the false positive specimen.

(iii) The Secretary shall review the laboratory's explanation within 5
working days and decide what further action, if any, to take.

(iv) If the error is determined to be an administrative error
(clerical, sample mixup, etc.), the Secretary may direct the laboratory to
take corrective action to minimize the occurrence of the particular error
in the future and, if there is reason to believe the error could have been
systematic, may require the laboratory to review and reanalyze previously
run specimens.

(v) If the error is determined to be a technical or methodological
error, the laboratory shall submit to the Secretary all quality control
data from the batch of specimens which included the false positive
specimen. In addition, the laboratory shall retest all specimens analyzed
positive by the laboratory from the time of final resolution of the error
back to the time of the last satisfactory performance test cycle. This
retesting shall be documented by a statement signed by the laboratory's
responsible person. Depending on the type of error which caused the false
positive, this retesting may be limited to one analyte or may include any
drugs a laboratory certified under these Guidelines must be prepared to
assay. The laboratory shall immediately notify the agency if any result on
a specimen that has been retested must be corrected because the criteria
for a positive are not satisfied. The Secretary may suspend or revoke the
laboratory's certification for all drugs or for only the drug or drug
class in which the error occurred. However, if the case is one of a less
serious error for which effective corrections have already been made, thus
reasonably assuring that the error will not occur again, the Secretary may
decide to take no further action. (vi) During the time required to resolve
the error, the laboratory shall remain certified but shall have a
designation indicating that a false positive result is pending resolution.
If the Secretary determines that the laboratory's certification must be
suspended or revoked, the laboratory's official status will become
"Suspended" or "Revoked" until the suspension or
revocation is lifted or any recertification process is complete.

(2) Requirement to Identify and Confirm 90 Percent of Total Drug
Challenges. In order to remain certified, laboratories must
successfully complete four cycles of PT per year. Failure of a certified
laboratory to maintain a grade of 90 percent over the span of two
consecutive PT cycles, i.e., to identify 90 percent of the total drug
challenges and to correctly confirm 90 percent of the total drug
challenges, may result in suspension or revocation of certification.

(3) Requirement to Quantitate 80 Percent of Total Drug Challenges at
±20 Percent or ±2 Standard Deviations. Quantitative values obtained
by a certified laboratory for at least 80 percent of the total drug
challenges must be ±20 percent or ±2 standard deviations (whichever
range is larger) of the appropriate reference or peer group mean as
measured over two consecutive PT cycles.

(4) Requirement to Quantitate within 50 Percent of Calculated
Reference Group Mean. After achieving certification a laboratory is
permitted one quantitative result differing by more than 50% from the
target value within two consecutive cycles of PT. More than one error of
this type within two consecutive PT cycles may result in a suspension or
proposed revocation.

(5)Requirement to Successfully Detect and Quantitate 50 Percent of
the Total Drug Challenges for Any Individual Drug. For any individual
drug, a certified laboratory must successfully detect and quantitate in
accordance with paragraphs (b)(2),(b)(3), and (b)(4) of this section at
least 50 percent of the total drug challenges.

(6) Procedures When Requirements in Paragraphs (b)(2) - (b)(5) of
this Section Are Not Met. If a certified laboratory fails to maintain
a grade of 90 percent over the span of two consecutive PT cycles after
initial certification as required by paragraph (b)(2) of this section or
if it fails to successfully quantitate results as required by paragraphs
(b)(3),(b)(4), or (b)(5) of this section, the laboratory shall be
immediately informed that its performance fell under the 90 percent level
or that it failed to quantitate test results successfully and how it
failed to quantitate successfully. The laboratory shall be allowed 5
working days in which to provide any explanation for its unsuccessful
performance, including administrative error or methodological error, and
evidence that the source of the poor performance has been corrected. The
Secretary may revoke or suspend the laboratory's certification or take no
further action, depending on the seriousness of the errors and whether
there is evidence that the source of the poor performance has been
corrected and that current performance meets the requirements for a
certified laboratory under these Guidelines. The Secretary may require
that additional performance tests be carried out to determine whether the
source of the poor performance has been removed. If the Secretary
determines to suspend or revoke the laboratory's certification, the
laboratory's official status will become "Suspended" or
"Revoked" until the suspension or revocation is lifted or until
any recertification process is complete.

(c) 80 Percent of Participating Laboratories Must Detect Drug. A
laboratory's performance shall be evaluated for all samples for which
drugs were spiked at concentrations above the specified performance test
level unless the overall response from participating laboratories
indicates that less than 80 percent of them were able to detect a drug.

(d) Participation Required. Failure to participate in a PT cycle
or to participate satisfactorily may result in suspension or revocation of
certification.

Section 3.20 Inspections.

(a) Frequency. Prior to laboratory certification under these
Guidelines and at least twice a year after certification, a team of three
qualified inspectors, at least two of whom have been trained as laboratory
inspectors, shall conduct an on-site inspection of laboratory premises.
Inspections shall document the overall quality of the laboratory setting
for the purposes of certification to conduct urine drug testing.
Inspection reports may also contain recommendations to the laboratory to
correct deficiencies noted during the inspection.

(b) Inspectors. The Secretary shall establish criteria for the
selection of inspectors to ensure high quality, unbiased, and thorough
inspections. The inspectors shall perform inspections consistent with the
guidance provided by the Secretary. Inspectors shall document the overall
quality of the laboratory's drug testing operation.

(c) Inspection Performance. The laboratory's operation shall be
consistent with good forensic laboratory practice and shall be in
compliance with these Guidelines. It is the laboratory's responsibility to
correct deficiencies identified during the inspection and to have the
knowledge, skill, and expertise to correct deficiencies consistent with
good forensic laboratory practice. Consistent with sections 3.13 and 3.14,
deficiencies identified at inspections may be the basis for suspending or
revoking a laboratory's certification.

Section 3.21 Results of Inadequate Performance.

Failure of a laboratory to comply with any aspect of these Guidelines
may lead to revocation or suspension of certification as provided in
sections 3.13 and 3.14 of these Guidelines.

Section 3.22 Listing of Certified Laboratories.

A Federal Register listing of laboratories certified by HHS will
be updated and published periodically. Laboratories which are in the
applicant stage of HHS certification are not to be considered as meeting
the minimum requirements in these Guidelines. A laboratory is not
certified until HHS has sent the laboratory an HHS letter of
certification.

Subpart D - Procedures for Review of Suspension or Proposed Revocation
of a Certified Laboratory.

Section 4.1 Applicability.

These procedures apply when:

(a) The Secretary has notified a laboratory in writing that its
certification to perform urine drug testing under these Mandatory
Guidelines for Federal Workplace Drug Testing Programs has been suspended
or that the Secretary proposes to revoke such certification.

(b) The laboratory has, within 30 days of the date of such notification
or within 3 days of the date of such notification when seeking an
expedited review of a suspension, requested in writing an opportunity for
an informal review of the suspension or proposed revocation.

Section 4.2 Definitions.

Appellant Means the laboratory which has been notified of its
suspension or proposed revocation of its certification to perform urine
drug testing and has requested an informal review thereof.

Respondent Means the person or persons designated by the
Secretary in implementing these Guidelines (currently the National
Laboratory Certification Program is located in the Division of Workplace
Programs, Substance Abuse and Mental Health Services Administration).

Reviewing Official Means the person or persons designated by the
Secretary who will review the suspension or proposed revocation. The
reviewing official may be assisted by one or more of his or her employees
or consultants in assessing and weighing the scientific and technical
evidence and other information submitted by the appellant and respondent
on the reasons for the suspension and proposed revocation.

Section 4.3 Limitation on Issues Subject to Review.

The scope of review shall be limited to the facts relevant to any
suspension or proposed revocation, the necessary interpretations of those
facts, the Mandatory Guidelines for Federal Workplace Drug Testing
Programs, and other relevant law. The legal validity of the Mandatory
Guidelines shall not be subject to review under these procedures.

Section 4.4 Specifying Who Represents the Parties.

The appellant's request for review shall specify the name, address, and
phone number of the appellant's representative. In its first written
submission to the reviewing official, the respondent shall specify the
name, address, and phone number of the respondent's representative.

Section 4.5 The Request for Informal Review and the Reviewing
Official's Response.

(a) Within 30 days of the date of the notice of the suspension or
proposed revocation, the appellant must submit a written request to the
reviewing official seeking review, unless some other time period is agreed
to by the parties. A copy must also be sent to the respondent. The request
for review must include a copy of the notice of suspension or proposed
revocation, a brief statement of why the decision to suspend or propose
revocation is wrong, and the appellant's request for an oral presentation,
if desired.

(b) Within 5 days after receiving the request for review, the reviewing
official will send an acknowledgment and advise the appellant of the next
steps. The reviewing official will also send a copy of the acknowledgment
to the respondent.

Section 4.6 Abeyance Agreement.

Upon mutual agreement of the parties to hold these procedures in
abeyance, the reviewing official will stay these procedures for a
reasonable time while the laboratory attempts to regain compliance with
the Mandatory Guidelines for Federal Workplace Drug Testing Programs or
the parties otherwise attempt to settle the dispute. As part of an
abeyance agreement, the parties can agree to extend the time period for
requesting review of the suspension or proposed revocation. If abeyance
begins after a request for review has been filed, the appellant shall
notify the reviewing official at the end of the abeyance period advising
whether the dispute has been resolved. If the dispute has been resolved,
the request for review will be dismissed. If the dispute has not been
resolved, the review procedures will begin at the point at which they were
interrupted by the abeyance agreement with such modifications to the
procedures as the reviewing official deems appropriate.

Section 4.7 Preparation of the Review File and Written Argument.

The appellant and the respondent each participate in developing the
file for the reviewing official and in submitting written arguments. The
procedures for development of the review file and submission of written
argument are:

(a) Appellant's Documents and Brief. Within 15 days after
receiving the acknowledgment of the request for review, the appellant
shall submit to the reviewing official the following (with a copy to the
respondent):

(1) A review file containing the documents supporting appellant's
argument, tabbed and organized chronologically, and accompanied by an
index identifying each document. Only essential documents should be
submitted to the reviewing official.

(b) Respondent's Documents and Brief. Within 15 days after
receiving a copy of the acknowledgment of the request for review, the
respondent shall submit to the reviewing official the following (with a
copy to the appellant):

(1) A review file containing documents supporting respondent's decision
to suspend or revoke appellant's certification to perform urine drug
testing, tabbed and organized chronologically, and accompanied by an index
identifying each document. Only essential documents should be submitted to
the reviewing official.

(2) A written statement, not exceeding 20 double-spaced pages in
length, explaining the basis for suspension or proposed revocation
(respondent's brief).

(c) Reply Briefs. Within 5 days after receiving the opposing
party's submission, or 20 days after receiving acknowledgment of the
request for review, whichever is later, each party may submit a short
reply not to exceed 10 double-spaced pages.

(e) Excessive Documentation. The reviewing official may take any
appropriate step to reduce excessive documentation, including the return
of or refusal to consider documentation found to be irrelevant, redundant,
or unnecessary.

Section 4.8 Opportunity for Oral Presentation.

(a) Electing Oral Presentation. If an opportunity for an oral
presentation is desired, the appellant shall request it at the time it
submits its written request for review to the reviewing official. The
reviewing official will grant the request if the official determines that
the decision- making process will be substantially aided by oral
presentations and arguments. The reviewing official may also provide for
an oral presentation at the official's own initiative or at the request of
the respondent.

(b) Presiding Official. The reviewing official or designee will
be the presiding official responsible for conducting the oral
presentation.

(c) Preliminary Conference. The presiding official may hold a
prehearing conference (usually a telephone conference call) to consider
any of the following: simplifying and clarifying issues; stipulations and
admissions; limitations on evidence and witnesses that will be presented
at the hearing; time allotted for each witness and the hearing altogether;
scheduling the hearing; and any other matter that will assist in the
review process. Normally, this conference will be conducted informally and
off the record; however, the presiding official may, at his or her discre-
tion, produce a written document summarizing the conference or transcribe
the conference, either of which will be made a part of the record.

(d) Time and Place of Oral Presentation. The presiding official
will attempt to schedule the oral presentation within 30 days of the date
appellant's request for review is received or within 10 days of submission
of the last reply brief, whichever is later. The oral presentation will be
held at a time and place determined by the presiding official following
consultation with the parties.

(e) Conduct of the Oral Presentation.

(1) General. The presiding official is responsible for
conducting the oral presentation. The presiding official may be assisted
by one or more of his or her employees or consultants in conducting the
oral presentation and reviewing the evidence. While the oral presentation
will be kept as informal as possible, the presiding official may take all
necessary steps to ensure an orderly proceeding.

(2) Burden of Proof/Standard of Proof. In all cases, the
respondent bears the burden of proving by a preponderance of the evidence
that its decision to suspend or propose revocation is appropriate. The
appellant, however, has a responsibility to respond to the respondent's
allegations with evidence and argument to show that the respondent is
wrong.

(3) Admission of Evidence. The rules of evidence do not apply
and the presiding official will generally admit all testimonial evidence
unless it is clearly irrelevant, immaterial, or unduly repetitious. Each
party may make an opening and closing statement, may present witnesses as
agreed upon in the prehearing conference or otherwise, and may question
the opposing party's witnesses. Since the parties have ample opportunity
to prepare the review file, a party may introduce additional documentation
during the oral presentation only with the permission of the presiding
official. The presiding official may question witnesses directly and take
such other steps necessary to ensure an effective and efficient
consideration of the evidence, including setting time limitations on
direct and cross-examinations.

(4) Motions. The presiding official may rule on motions
including, for example, motions to exclude or strike redundant or
immaterial evidence, motions to dismiss the case for insufficient
evidence, or motions for summary judgment. Except for those made during
the hearing, all motions and opposition to motions, including argument,
must be in writing and be no more than 10 double-spaced pages in length.
The presiding official will set a reasonable time for the party opposing
the motion to reply.

(5) Transcripts. The presiding official shall have the oral
presentation transcribed and the transcript shall be made a part of the
record. Either party may request a copy of the transcript and the
requesting party shall be responsible for paying for its copy of the
transcript.

(f) Obstruction of Justice or Making of False Statements.
Obstruction of justice or the making of false statements by a witness or
any other person may be the basis for a criminal prosecution under 18
U.S.C. 1505 or 1001.

(g) Post-hearing Procedures. At his or her discretion, the
presiding official may require or permit the parties to submit
post-hearing briefs or proposed findings and conclusions. Each party may
submit comments on any major prejudicial errors in the transcript.

Section 4.9 Expedited Procedures for Review of Immediate Suspension.

(a) Applicability. When the Secretary notifies a laboratory in
writing that its certification to perform urine drug testing has been
immediately suspended, the appellant may request an expedited review of
the suspension and any proposed revocation. The appellant must submit this
request in writing to the reviewing official within 3 days of the date the
laboratory received notice of the suspension. The request for review must
include a copy of the suspension and any proposed revocation, a brief
statement of why the decision to suspend and propose revocation is wrong,
and the appellant's request for an oral presentation, if desired. A copy
of the request for review must also be sent to the respondent.

(b) Reviewing Official's Response. As soon as practicable after
the request for review is received, the reviewing official will send an
acknowledgment with a copy to the respondent.

(c) Review File and Briefs. Within 7 days of the date the
request for review is received, but no later than 2 days before an oral
presentation, each party shall submit to the reviewing official the
following: (1) a review file containing essential documents relevant to
the review, tabbed, indexed, and organized chronologically, and (2) a
written statement, not to exceed 20 double-spaced pages, explaining the
party's position concerning the suspension and any proposed revocation. No
reply brief is permitted.

(d) Oral Presentation. If an oral presentation is requested by
the appellant or otherwise granted by the reviewing official, the
presiding official will attempt to schedule the oral presentation within
7-10 days of the date of appellant's request for review at a time and
place determined by the presiding official following consultation with the
parties. The presiding official may hold a pre-hearing conference in
accordance with section 4.8(c) and will conduct the oral presentation in
accordance with the procedures of sections 4.8(e),(f),and (g).

(e) Written Decision. The reviewing official shall issue a
written decision upholding or denying the suspension or proposed
revocation and will attempt to issue the decision within 7-10 days of the
date of the oral presentation or within 3 days of the date on which the
transcript is received or the date of the last submission by either party,
whichever is later. All other provisions set forth in section 4.14 will
apply.

(f) Transmission of Written Communications. Because of the
importance of timeliness for these expedited procedures, all written
communications between the parties and between either party and the
reviewing official shall be by facsimile or overnight mail.

Section 4.10 Ex parte Communications.

Except for routine administrative and procedural matters, a party shall
not communicate with the reviewing or presiding official without notice to
the other party.

Section 4.11 Transmission of Written Communications by Reviewing
Official and Calculation of Deadlines.

(a) Because of the importance of a timely review, the reviewing
official should normally transmit written communications to either party
by facsimile or overnight mail in which case the date of transmission or
day following mailing will be considered the date of receipt. In the case
of communications sent by regular mail, the date of receipt will be
considered 3 days after the date of mailing.

(b) In counting days, include Saturdays, Sundays, and holidays.
However, if a due date falls on a Saturday, Sunday, or Federal holiday,
then the due date is the next Federal working day.

Section 4.12 Authority and Responsibilities of Reviewing Official.

In addition to any other authority specified in these procedures, the
reviewing official and the presiding official, with respect to those
authorities involving the oral presentation, shall have the authority to
issue orders; examine witnesses; take all steps necessary for the conduct
of an orderly hearing; rule on requests and motions; grant extensions of
time for good reasons; dismiss for failure to meet deadlines or other
requirements; order the parties to submit relevant information or
witnesses; remand a case for further action by the respondent; waive or
modify these procedures in a specific case, usually with notice to the
parties; reconsider a decision of the reviewing official where a party
promptly alleges a clear error of fact or law; and to take any other
action necessary to resolve disputes in accordance with the objectives of
these procedures.

Section 4.13 Administrative Record.

The administrative record of review consists of the review file; other
submissions by the parties; transcripts or other records of any meetings,
conference calls, or oral presentation; evidence submitted at the oral
presentation; and orders and other documents issued by the reviewing and
presiding officials.

Section 4.14 Written Decision.

(a) Issuance of Decision. The reviewing official shall issue a
written decision upholding or denying the suspension or proposed
revocation. The decision will set forth the reasons for the decision and
describe the basis therefor in the record. Furthermore, the reviewing
official may remand the matter to the respondent for such further action
as the reviewing official deems appropriate.

(b) Date of Decision. The reviewing official will attempt to
issue his or her decision within 15 days of the date of the oral
presentation, the date on which the transcript is received, or the date of
the last submission by either party, whichever is later. If there is no
oral presentation, the decision will normally be issued within 15 days of
the date of receipt of the last reply brief. Once issued, the reviewing
official will immediately communicate the decision to each party.

(c) Public Notice. If the suspension and proposed revocation are
upheld, the revocation will become effective immediately and the public
will be notified by publication of a notice in the Federal Register.
If the suspension and proposed revocation are denied, the revocation will
not take effect and the suspension will be lifted immediately. Public
notice will be given by publication in the Federal Register.

Before any legal action is filed in court challenging the suspension or
proposed revocation, respondent shall exhaust administrative remedies
provided under this subpart, unless otherwise provided by Federal Law. The
reviewing official's decision, under section 4.9(e) or 4.14(a),
constitutes final agency action and is ripe for judicial review as of the
date of the decision.